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UltraSeal XT® plus - Åhrén Dental Consult
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1. GA e gS s LARA 2 Dn eked SAC DORAUS 45 KOMSDS K lt DUO Alc CE SEA HH LOVER E EE 8 HADH 9 PI Ultradent HEEE Ao WEG EME SEE ED GR FERAE RD 218839 53220851 WAS DBS A Ultra Etch SX UltraSeal XT plus PrimaDry AA EARED Et o FEE as EA QUI EE EY fa SR ih AS EAA TipSoc E Pi aL 5 l pA RE 10 11 T2 13 14 a TEAR EAD 9 Ultradentg
2. 9 Brug Ultradent Sprojteposer og eller reng r og desinfic r sprojterne efter hver patient 10 Brug almindelig polymeriseringslampe til alle lysheerdende materialer 11 Alle spidser er til engangsbrug 12 Fors g aldrig at tilf re Ultra Etch eller UltraSeal XT plus gennem den sorte mini borstespids 13 PrimaDry er brandfarligt H ndteres med forsigtighed 14 For at forhindre udtorring af flygtige materialer sasom PrimaDry seettes luerl sheetterne pa igen nar sprojterne ikke er i anvendelse alternativt anvendes TipSoc deeksler 8 l k yt liikaa voimaa painaessasi ruiskun m nt 9 K yt Ultradent ruiskunsuojaa ja tai puhdista ruisku potilaiden v lill 10 K yt standardisoituja valokovettajia kaikkien valokovetteisten materiaalien kanssa 11 Kaikki k rjet ovat kertakayttoisa 12 Ala koskaan yrita annostella Ultra Etch tai UltraSeal XT plus valmistetta Black Mini Brush karjen kautta 13 PrimaDry on syttyv K sittele varovasti 14 Aseta luer lock tulpat paikoilleen kun ruiskuja ei kayteta tai kayta TipSoc suojuksia jotta haihtuvat materi
3. 10 11 12 Ultra Etch UltraSeal XT plus Black Mini Brush 13 PrimaDry 14 PrimaDry TipSoc 10 FA EZ 11 7 1 12 Ultra Etch amp 7c tX UltraSeal XTZ 7 ARABS DEIA Black Mini Brush
4. JA 74 ip Blue Micro Tip Inspiral Brush Tip Work UltraSeal XT plus into surface Light cure 20 seconds PrimaDry 5 seconds gently air dry Significantly enhances seal D UltraSeal XT plus in die Oberfl che einarbeiten 20 Sek lichtharten PrimaDry 5 Sek lang einb rsten sanft mit Luft verblasen Dies verstarkt wesentlich die Haftung Travailler UltraSeal XT sur la surface Photopolym riser pendant 20 secondes Appliquer PrimaDry 5 secondes s cher d licatement l air Am liore significativement le scellement D Glazuur opruwen met Fissure prep boor luchtabrasie e d 4 Ripassare lo smalto con la diamantata Fissure Prep Bur la sabbiatura ecc Prepare el esmalte usando la fresa Fissure Prep aire abrasivo etc Refrescar o esmalte com Fissure Prep Bur buril de preparac o de fissuras abras o por ar etc lt Frascha upp emalj med Fissure Prep Bur luftolastring mm Opfrisk emalje vha fissur prepbor luftabrasion osv lt N Uudista kiillett Fissure Prep teralla ilmahionnalla jne lt Dpeox pete CUAATO ue xpron ekyAvgidac TIPOETOLLAGLAG OXLGLOV an eon KTA Gedurende 15 seconden met Ultra Etch etsen Lucht waterspoeling gedurende 5 seconden Drog
5. 11 12 Ultra Etch UltraSeal plus c Black Mini Brush 13 PrimaDry c 14 PrimaDry TipSoc qv Og lne rodki ostro no ci 1 Preparat wy cznie do profesjonalnych zastosowa 2 Przed rozpocz ciem leczenia nale y zapozna si z instrukcjami rodkami ostro no ci oraz kart charakterystyki bezpiecze stwa materia u Stosowa dok adnie wed ug instrukcji 3 Materia y nale y przechowywa z dala od r de ciep a i promieni s onecznych 4 Unika wystawiania sk ry na dzia anie ywic 5 Ograniczy stosowanie silnych zwi zk w chemicznych do leczonego obszaru 6 Potwierdzi czy u pacjenta nie wyst puje znane uczulenie na materia y stosowane w leczeniu 7 Przed u yciem w obr bie jamy ustnej sprawdzi wyp yw materia w ze strzykawk
6. ta na RU XpaHuTb PL Przechowywac w miejscu niedostepnym dla dzieci TK ocuklardan uzak tutun AR gle ent ba KR 0 2lo 20 SAl ei xol TERMES Jho FO lt Pic t EN Dentist Dispensed DE Vom Zahnarzt abzugeben FR Distribu par le chirurgien dentiste NL Door de tandarts verstrekt T Prescritto dal dentista ES Administrado por el Dentista PT Administrado pelo dentista SV Appliceras av tandl kare DA Administreret af tandleege Fl Hammaslaakarin k ytt n EL Atav petat DIROT PL Wydaje sie z przepisu dentysty TK Disci tarafindan AR GU KR x uLe ur AES A CH FR Van FLOS bi HP GRAY FH 912416 DE AuBerhalb der Reichweite von Kindern aufbewahren FR Tenir hors de port e des enfants NL Buiten bereik van kinderen houden IT Tenere fuori dalla portata dei bambini ES Mant ngase fuera del alcance de los ni os 46 36 DE Empfohlene Lager Temperatur FR Temp rature de stockage recommand e NL Aanbevolen bewaartemperatuur IT Temperatura di stoccaggio consigliata 8 ES Temperatura Recomendada Para Almacenamiento 2
7. PL Nie nadaje sie do iniekcji TK eee edilmek i icin kullanilmaz KR elo Six CH IEDR SH JA JETTSN AA Teg ULTRADENT PRODUCTS INC a MATERIAL SAFETY DATA SHEET Controlled Product No Vf SECTION I IDENTIFICATION OF THE SUBSTANCE PREPARATION AND OF THE COMPANY UNDERTAKING Material UltraSeal XT plus Manufactured by Ultradent Products Inc Name 505 West 10200 South Marne South Jordan Utah 84095 USA s Emergency 1 800 552 5512 or 1 801 572 4200 Outside USA Date August 29 1997 EC Representative Prepared by Steve Jensen Chemist SECTION II COMPOSITION INFORMATION ON INGREDIENTS gt Approximate LDso LCso Active Ingredients Concentration 96 Specify Species and Route C A S N A or U N Numbers Bis GMA proprietary Not established 1565 94 2 Pit and Fissure Sealant and Flowable Composite SECTION Ill HAZARDS IDENTIFICATION Adverse Human May cause sensitization Effects and Symptoms SECTION IV FIRST AID MEASURES Inhalation N A Eye Contact Flush with lots of water Call a physician if needed Ingestion Wash with soap and water In large amounts induce vomiting SECTION V FIRE FIGHTING MEASURES Flammability If Yes Under Yes No Which Conditions Means of 1 Protective Equipment Extinction dry chemical for Firefighters Standard ECTION VI ACCIDENTAL RELEASE MEASURE SE
8. Conservare i prodotti al riparo dal calore e dall esposizione diretta alla luce del sole Evitare l esposizione della pelle alle resine La presenza di prodotti chimici forti deve essere isolata all area di trattamento Verificare che il paziente non sia allergico ai prodotti scelti per il trattamento e Precauciones Generales 1 Para uso exclusivo de Profesionales 2 Antes de empezar el tratamiento revise las instrucciones precauciones y el MSDS Siga las instrucciones Siempre mantenga los productos alejados del calor y de la luz solar Evite el contacto de las resinas con la piel Aisle los qu micos fuertes del rea de tratamiento Aseg rese que el paciente no es al rgico a los materiales Antes de usar en la boca verifique que los materiales fluyan de la jeringa y la punta lt Precauc es gerais 1 2 Y O gt Y 8 an 2 Ga iu go Ce Somente para uso profissional Ler instru es precau es e MSDS antes de come ar o tratamento Utilizar s como indicado Manter os produtos longe do calor e da luz solar directa Evitar contacto com a pele Aplicar subst ncias qu micas fortes s na rea de tratamento Confirmar se os pacientes n o tem alerg as aos materiais utilizados lestar o escoamento dos materiais atrav s da seringa e ponta antes da aplicac o intraoral Nunca for ar os mbolos da seringa nerella forsiktigh
9. Protection Protection SECTION IX PHYSICAL amp CHEMICAL PROPERTIES Odor Ethyl alcohol odor Other Data Rapid evaporation rate 99 volatile SECTION X STABILITY AND REACTIVITY Chemical Stability Conditions and Strong oxidizing agents Hazardous Decomposition Yes No V Materials to Avoid Products SECTION XI TOXICOLOGICAL INFORMATION Route of Entry Skin Contact Skin Absorption vf Eye Contact Inhalation Acute Inhalation Chronic vf Ingestion Effects and Symptoms Eyes Irritation of Short Term Exposure Chronic Effects and Symptoms of Long Term Exposure of Product SECTION XII ECOLOGICAL INFORMATION SECTION XIII DISPOSAL CONSIDERATIONS Waste Disposal SECTION XIV TRANSPORT INFORMATION SECTION XV REGULATORY INFORMATION SECTION XVI OTHER INFORMATION FOR DENTAL USE ONLY Use as directed The information and recommendations are taken from sources raw material MSDS s and manufacturer s knowledge believed to be accurate however Ultradent Products Inc makes no warranty with respect to the accuracy of the information or the suitability of the recommendation and assumes no liability to any user thereof Each user should review these recommendations in the specific context of the intended use and determine whether they are appropriate Eyes Irritation Ingestion Irritation burning of throat UltraSeal XT plus Ultra Etch PrimaDry Fla
10. PT Temperatura de armazenagem aconselhada Y SV Rekommenderad F rvarings Temperatur DA Anbefalet Opbevaringstemperatur Fl Suositeltu sailytyslampotila EL Lvviotwpevn 7 00 6 6 PL Zalecana temperatura przechowywania TK Onerilen saklama s cakl AR Lo yaya js 453 5 5 gt ESAS kp AS OMA Ce Yim TH lt EZV EN Destroy after use DE Nach Gebrauch vernichten FR D truire apr s utilisation NL Na gebruik vernietigen IT Distruggere dopo l uso ES Destr yalo despu s de usarlo PT Destruir ap s usar SV F rstores efter anv ndning DA Destru r efter brug Fl Havita k yt n j lkeen EL Kataotp wte TO peta Tn xprjon PL Po uzyciu zniszczyc TK Kullandiktan sonra imha edin AR Wl es cabo KR AHE EAE 54 CH H ien 7 TH nada JA f FH fe RS L lt ZZ v JAHRE JE EN Not for injection DE Nicht zur Injektion FR Ne pas injecter NL Niet injecteren IT Non per iniezione ES No debe inyectarse PT N o injectar SV Ej for injektion DA Ikke til injektion FI Ei injektiokayttoon EL Mn v otpo RU He
11. 5 Wi Salt ig Ek NAA ME Ey TE PrimaDry 5 PrimaDryZe 5 b B f FH Ly HES EAERI 9 HD CHET C cO es UltraSeal XT plus CBeTOM B 20 Nalozyc UltraSeal XT plus Utwardzac wiat em lampy polimeryzacyjnej przez 20 sekund Y zeye UltraSeal XT plus uygulay n 20 saniye boyunca kla sertle tirin 3 98 del ON Gale G5 pa cala cau 14 43620 534 3 5404 UltraSeal AA 20272 Asta HAIL IS UltraSeal XT plus FRA JE 20 fb UltraSeal XT plus 20 sez WYK 2 It Ze L d ds Precautions 1 For Professional use only 2 Review instructions precautions and MSDS before beginning treatment Use only as directed Keep products out of heat sunlight Avoid skin exposure to resins Isolate strong chemicals to area of treatment e OND Oe Go Never force syringe plungers Precautions 1 Nur f r professionellen zahnmedizinischen Gebrauch 2 Lesen Sie die Gebrauchsinformationen und Warnhinweise sorgfaltig bevor Sie die Behandlung beginnen Verwenden Sie die Materialien
12. HEHEH FEA XI zx 8 Nigdy nie wywiera nadmiernej si y na t ok strzykawki 9 U ywa foliowych pokrowc w na strzykawki Ultradent Syringe Covers lub czy ci oraz dezynfekowa strzykawki przed u yciem u nast pnego pacjenta 10 Do polimeryzacji lub aktywowania materia w wiat outwardzalnych lub aktywowanych wiat em nale y stosowa standardowe lampy polimeryzacyjne u ywane w stomatologii 11 Wszystkie aplikatory ko cowki s jednorazowe 12 Nie wolno stosowa aplikatora ko cowki Black Mini Brush tip czarna z delikatnym p dzelkiem do aplikacji Ultra Etch i UltraSeal XT plus 13 Preparat PrimaDry jest atwopalny Nale y zachowa ostro no 14 Aby zapobiec wysychaniu atwo paruj cych preparat w takich jak PrimaDry nale y gdy nie s u ywane zawsze zabezpiecza strzykawki zakr tk lub zak ada na aplikatory pokrowce TipSoc 8 r nga pistonunu asla zorlamay n 9 Ultradent Syringe Covers kullan n ve veya hastalarda kullanmadan nce r ngalar dezenfekte edin 10 T m kla polimerize aktive edilen maddelerle al rken standart sertle tirici k kullan n 11 T m u lar kullan at tipindedir 12 Ultra Etch ya da UltraSeal XT plus Siyah Mini F r a u la uygulamay1 asla denemeyin 13 PrimaDry yanicidir Dikkatlice kullanin 14 PrimaDry gibi u ucu malzemelerin kurumas n nlemek i in siringay1 kullanmiyorken luer kilidi kapaklar n takin
13. IV FIRST AID MEASURES Inhalation N A CR Flush immediately with water Get medical attention Skin Fl Ingestion Do not induce vomiting Give large amounts of water ush with water 9 i 5 mc Contact or milk Take an antacid Calla physician SECTION V FIRE FIGHTING MEASURES Flammability If Yes Under Yes No Y Which Conditions M f Protective Equi t Extinction N A for Firefighters N A ECTION VI ACCIDENTAL RELEASE MEASURE SECTION VII HANDLING AND STORAGE Personal amp Environmental Avoid contact with skin eyes and clothing Handling Use gloves and protective eyewear Precautions Prevent contamination of soil drains etc Precautions Methods for C Storage Cleaning Requirements SECTION VIII EXPOSURE CONTROLS PERSONAL PROTECTION Respiratory N A Eye Protection Protection Hand Protection SECTION IX PHYSICAL amp CHEMICAL PROPERTIES Appearance Blue gel Ultra Etch Light blue gel Ultra Etch AB En esas Not defined Ge E SECTION X STABILITY AND REACTIVITY Chemical Stability Conditions and Hazardous Decomposition Yes V No Materials to Avoid Products Oxides of phosphorus SECTION XI TOXICOLOGICAL INFORMATION Route of Entry V Skin Contact Skin Absorption vf Eye Contact Inhalation Acute Inhalation Chronic vf Ingestion Effects and Symptoms of Short Term Exposure Chronic Effects and Symptoms of Long Term Exposure Sensitization N A Irritancy Mild of Product i SECTION XII ECOLOGICAL INFO
14. Todas las puntas son desechables 12 No intentar nuca aplicar Ultra Etch o UltraSeal XT plus mediante la punta Black Mini Brush 13 PrimaDry es inflamable Man jese con cuidado 14 Para evitar que se sequen los materiales vol tiles como el PrimaDry coloque los tapones con cierre luer cuando no use las jeringas o use las tapas TipSoc 11 12 13 14 9 Utilizar protectores de seringa Ultradent e ou desinfectar seringas entre cada tratamento 10 Utilizar luzes de polimeriza o standard com todos os materiais fotopolimeriz veis 11 As pontas sao todas descart veis 12 Nunca administre Ultra Etch ou UltraSeal XT plus atrav s da ponta Black Mini Brush 13 0 PrimaDry inflam vel Manuseie com cuidado 14 Para evitar a secagem de materiais vol teis nomeadamente PrimaDry volte a colocar as tampas Luer Lock quando nao estiver a utilizar as seringas ou utilize tampas TipSoc Tvinga ej med vald eller hart tryck pistongen i sprutan Anv nd Ultradent sprutskydd och eller reng r sprutor mellan patienter Anv nd vanlig ljush rdningslampa till alla ljusaktiverade polymeriseringsmaterial Alla spetsar ar avsedda for engangsbruk F rs k aldrig applicera Ultra Etch eller UltraSeal XT plus genom Black Mini Brush spetsen PrimaDry ar brandfarligt Hanteras forsiktigt F r att undvika att flyktiga material som PrimaDry torkar m ste man s tta tillbaka luer forslutningarna nar injektionsspr
15. nur gem Vorschrift 3 Sch tzen Sie die Produkte vor Hitze und direktem Sonnenlicht 4 Vermeiden Sie Hautkontakt mit Kunststoff Materialien 5 Beschranken Sie den EinfluB stark wirkender Agenzien auf das Behandlungsgebiet Fragen Sie den Patient nach bekannten Allergien auf die zur Behandlung verwendeten Materialien 7 Pr fen Sie den FluB des Materials aus der Spritze und durch den Spritzenansatz bevor Sie intraoral applizieren 6 e Pr cautions g n rales 1 Exclusivement r serv l usage professionnel 2 Voir les instructions les pr cautions et la notice de s curit avant le traitement Utiliser uniquement selon les instructions Tenir les produits l abri de la lumi re du soleil et de la chaleur Eviter le contact des r sines avec la peau Limiter l application des produits aux seules zones de traitement S assurer que le patient ne pr sente aucune allergie aux produits utilis s lors du traitement Tester le d bit des mat riaux travers les seringues et les embouts d application avant toute utilisation intra buccale Ne jamais forcer sur le piston des seringues DAA lt Algemene voorzorgsmaatregelen 1 Uitsluitend bestemd voor aflevering aan en toepassing door tandartsen 2 Raadpleeg gebruiksaanwijzingen en houd rekening met de daarin genoemde aanbevelingen Gebruik alleen zoals is beschreven Bewaar de producten koel en donker Vermijd huidcontact met harsen Appliceer alleen daar waar n
16. ya da TipSoc kapaklari kullanin jd adi La all O fos ca ubi eo 2 9 4 3 e pall aLall 3 AS i 4 cst Laila le 5 ay Y ya pall oj asl 6 s ll a mg di Gul BN GDL Ba ge 7 9 Ultradent Syringe Cover amp ALSS Set FAPIE CS ALS 57 Mol AH SL 10 hes Cle Ce 1 22 H2 esser 12 Black Mini Brush ES Sal Ultra Etch EE UltraSeal XT 2423 ELEN O c c EI E H 14 Y2 SHA ols SAO okt A HAE SE He Sol te AS Bol H SAL HHE S RRETA ER SR A EEA AR Alas cat la D I IE RR Je PASH WORE ERB BA EE So E S JG BG BV 6 PZ Fill A B o ig FB ZG TE MA SABIAN AO AEA Z Bl SB ACRI BES St fel T SME SLE EUH ADURO ME Ls P 2 MSDS
17. CTION VII HANDLING AND STORAGE Personal amp Environmental Handling Precautions None Precautions Methods for Wipe up as much as possible with dry cloth Storage Cleaning Clean remainder with alcohol Requirements SECTION VIII EXPOSURE CONTROLS PERSONAL PROTECTION Respiratory N A Eye Protection Protection Avoid contact with open flame None Refrigerate when not in use Protective eyewear Hand Latex gloves Skin Protection E Protection Lab coat SECTION IX PHYSICAL amp CHEMICAL PROPERTIES Appearance Tinted liquid rend Insoluble Xue RN N A Odor Slight acrylic odor pH N A Other Data None SECTION X STABILITY AND REACTIVITY Chemical Stability Conditions and Light exposure will initiate polymerization Hazardous Decomposition Yes No vf Materials to Avoid Products SECTION XI TOXICOLOGICAL INFORMATION Route of Entry V Skin Contact Skin Absorption vf Eye Contact Inhalation Acute Inhalation Chronic Ingestion Effects and Symptoms Skin Slight irritation Eye Slight irritation of Short Term Exposure Chronic Effects and Symptoms of Long Term Exposure Sensitization Slight possibility pcia MN Slight SECTION XII ECOLOGICAL INFORMATION SECTION XIII DISPOSAL CONSIDERATIONS Biodegradability N A Disposal Further Details None In accordance with government regulations SECTION XIV TRANSPORT INFORMATION SECTION XV REGULATORY INFORMATION SECTION XVI OTHER INFORMATION FO
18. F v 72H L Z 3 Ma IBN HOGAZEXEU C lt WK Je EV 4 BOSE MBAS IC BARA KE DIC UC 13 PrimaDrylk uJWA cd Ta us 5 ARDS BIAR RIOS EL FO bY 14 PrimaDry7 amp UTERO HIRE BG CID 6 SL 77 152 707 lc 7 a ENCENS Zo 3 opea N S Ultradent YY VY AIN HAT AD ISS 21 UYU LULZETwZAb5HM w 703v TARTA ZDT lt EEZ amp 7ci amp TipSocZ73 ec HN Ge cu o wid WA UT lt TEKS EN Key IT Legenda Fl Merkkien selitykset DE Legende ES Clave EL KAei t KR S 2 FR Explication PT Legenda CH THEIR NL Erkl rung der SV Teckenf rklaring PL Legenda TH MAY Packungssymbole DA Tegnforklaring TK Anahtar JA amp X EN Irritant ES Irritante El Epe9totix AE DE Irritierend PT Irritante 7 FR Irritant SV Irriterande PL Srodek drazniacy NL lrriterend DA Lokalirriterende TK Tahrig edici JAR FEE T Irritante Fl Arsyttava EN Keep out of reach of children ep EN Recommended storage temperature PT Manter fora do alcance das criangas SV Forvaras utom r ckh ll for barn DA Opbevares utilgaengelig for born Fl Pidettava poissa lasten ulottuvilta
19. M e J X DITF 7 7 WHEL Ultra Etch 15 B 5 Nalozy wytrawiacz Ultra Etch na 15 sekund Splukiwac sprayem powietrzno wodnym przez 5 sekund Osuszyc powietrzem dmuchawki 15 saniye boyunca Ultra Etch 5 saniye boyunca hava su ile yikayin Hava ile kurutun Bae 5 en 05 15 Em Ultra Etch 1527 H HAL 27 55 zt MO 21 gt EA Ultra Etch ZG 15 599 HR 7K 5 Hee Alt Ultra Etch 15 5 Ultra Etch7e 15 Fal le IET 4 NE 4 d PrimaDry na 5 PrimaDry to preparat poprawiajacy sile wiazania i szczelno laku PrimaDry nak ada sie na 5 sekund a nastepnie osusza delikatnie powietrzem dmuchawki 5 saniye PrimaDry havayla hafifce kurutun Dolgu malzemesinin performansini nemli l de art r r ghala Til ei el 9 5 534 PrimaDry amp 522 HAL SE BS ds a 7L ui cH o Bi EA PrimaDry FF
20. R DENTAL USE ONLY Use as directed The information and recommendations are taken from sources raw material MSDS s and manufacturer s knowledge believed to be accurate however Ultradent Products Inc makes no warranty with respect to the accuracy of the information or the suitability of the recommendation and assumes no liability to any user thereof Each user should review these recommendations in the specific context of the intended use and determine whether they are appropriate Skin Low possiblility of sensitization upon prolonged exposure Eye Slight irritation igs ULTRADENT PRODUCTS INC a MATERIAL SAFETY DATA SHEET Controlled Product Yes No vf SECTION I IDENTIFICATION OF THE SUBSTANCE PREPARATION AND OF THE COMPANY UNDERTAKING Material Ultra Etch Manufactured by Ultradent Products Inc Name 505 West 10200 South UCET Etching of tooth enamel and dentin South Jordan Utah 84095 USA Emergency 1 800 552 5512 or 1 801 572 4200 Outside USA Contact Date June 10 1997 EC Representative Prepared by Steve Jensen Chemist SECTION II COMPOSITION INFORMATION ON INGREDIENTS e Approximate LDso LCso Active Ingredients Concentration 96 Specify Species and Route Phosphoric Acid 35 LD 1530 mg kg 7664 38 2 Oral Rat SECTION HAZARDS IDENTIFICATION Adverse Human Irritates eyes and skin Effects and Symptoms SECTION
21. RMATION SECTION XIII DISPOSAL CONSIDERATIONS Biodegradability Not defined Method of i Waste Disposal In accordance with governmental regulations lean up with wet reg Neutralize with baking soda Store at room temperature Protective eyewear Latex gloves Skin Lab coat Protection Skin May cause irritation Eyes Severe irritation Ingestion Possible irritation Skin Mild irritation Eyes Damage chronic exposure must be avoided Ingestion Irrigation Further Details N A SECTION XIV TRANSPORT INFORMATION SECTION XV REGULATORY INFORMATION SECTION XVI OTHER INFORMATION FOR DENTAL USE ONLY Use as directed The information and recommendations are taken from sources raw material MSDS s and manufacturer s knowledge believed to be accurate however Ultradent Products Inc makes no warranty with respect to the accuracy of the information or the suitability of the recommendation and assumes no liability to any user thereof Each user should review these recommendations in the specific context of the intended use and determine whether they are appropriate Ted ULTRADENT PRODUCTS INC R l A L SA F ETY DATA S H E ET Controlled Product Yes No Y SECTION I IDENTIFICATION OF THE SUBSTANCE PREPARATION AND OF THE COMPANY UNDERTAKING Material PrimaDry Manufactured by Ultradent Products Inc Namie 505 West 10200 South Mat
22. ULTRADENT PRODUCTS INC Description e hixotropic resin sealant that penetrates into occlusal Thixotropic 58 filled grooves when used with the UltraSeal XT plus flows out of a syringe through the Inspiral Brush tip that allows helical channel of the Inspiral for shear thinning effect of Brush tip the sealant e 58 filled for optimum strength UltraSeal XT plus in conjunction with PrimaDry drying and priming agent virtually eliminates microleakage Radiopaque Indications Use UltraSeal XT plus for prophylactic sealing of pits and fissures Preliminary Procedure 1 2 3 Remove luer lock cap from Ultra Etch 35 phosphoric acid syringe Firmly twist a disposable Inspiral Brush tip or Blue Micro tip onto syringe Remove luer lock cap from 1 2 ml PrimaDry syringe Firmly twist either a Black Mini Brush or a Blue Micro tip onto syringe Remove luer cap from UltraSeal XT plus syringe Firmly twist an Inspiral Brush tip or a Black Micro FX tip onto syringe Clean fissures with a prophy jet type device high pressure air abrasion or a thin diamond bur We recommend the Fissure Prep Bur to remove enamel pellicle etc If using a prophy jet type device with sodium bicarbonate it is advised to etch twice The first application neutralizes the sodium bicarbonate the second conditions the enamel Hold syringe in palm of hand for optimum control rather than in conventional manner with thum
23. aalit kuten PrimaDry eivat kuivu 8 Mm not EuBoro ovptyyac 9 Na 7 ovptyyov trc Ultradent kat va KaBapicete xat va amoAvpatvere Tic peta vov ao0evov 10 Na xpnotponoteire Kou 60 6 10707 80 6 yia dha 11 OAec ot eivai 06 6 12 Mny emtyetpnoete not va Ultra Etch UltraSeal XT plus p ow TNG LOTS 6 016 6 13 To PrimaDry eivat 7 10 Xeipiote re poooyn 14 Iia va 0 thy Enpavon vov 09 roc PrimaDry Fava ta luer lock Sev 0 6 070 obptyyec 7 TipSoc 9 Ultradent 10
24. b on plunger Etch Dry and Prime Cure Procedure Pit amp Fissure Sealants Etch 1 Isolate teeth with rubber dam or appropriate absorbent devices such as cotton rolls etc Moisture contamination either in liquid or vapor form just prior to resin placement will compromise bond and seal 2 Deliver Ultra Etch to fissure using the Inspiral Brush tip or the Blue Micro tip according to preference Etch with Ultra Etch for 15 20 seconds then rinse with full air water spray and dry Dry and Prime Apply PrimaDry and leave 5 seconds Dry by gently blowing area with moisture free and oil free air don t rinse Note PrimaDry significantly enhances bond and seal of UltraSeal XT plus Remember fissures are not empty spaces Organic matter in the fissures can act like a sponge supplying moisture contamination PrimaDry rapidly volatilizes moisture content of fissures Note Most dental 3 way syringes deliver moist contaminants with air Use Aquav to evaluate moisture content of air in 3 way syringe Note If applying to dentin use a dentin bonding agent such as PQ Clear in place of PrimaDry for both dentin and enamel Do not use PrimaDry as a dentin bonding agent Seal The Inspiral bristle length can be customized by grasping bristles between thumb and finger and moving them in or out A shorter length is desirable to stiffen the brush We recommend about 2 1 2mm in length Express a small drop of sealant at t
25. egler amp flieBf higes Composite FR Scellement de fissure et composite fluide NL Fissuursealend vloeibaar composietmateriaal IT Sigillante per solchi e composito scorrevole ES Sellador de fisuras y composite fluido PT Selante de fissuras e composto dispers vel SV Sprickt tningsmedel med flytande sammans ttning DA Fissurforsegling og komposit der kan flyde Fl Fissuuroiden pinnoite ja valuva yhdistelm muovi EL Vlux 6 6 oxiopov Kat vAtk ANOKATAOTAGEWV VYNANG PEVOT TNTAG Inspiral Brush Tip Blue Micro T Ultra Etch 15 seconds Air water wash 5 seconds Air dry Freshen enamel using Fissure Prep Bur air abrasion etc lt Schmelz anrauhen durch Diamantfinierer Mikro Sandstrahl o Ultra Etch applizieren 1 Mit Luftbl ser trocknen e Rafraichir l mail avec une fraise de pr paration de fissure une abrasion l air etc Appliquer Ultra Etch pendant 15 secondes 5 secondes S cher l air raSeal XT plus Sek einwirken lassen 5 oek mit Spray absp len Laver l eau air pendant TM Fissure sealant and flowable composite RU IL10M6uponso nbrit Fe PL Lak do bruzd i szczelin plynny kompozyt TK Catlak dolgu malzemesi ve akiskan kompozit E AR Shpall 9 9S KR IE AGE SAMS PA eene
26. en met lucht Ultra Etch 15 secondi Sciacquo aria acqua 5 secondi Asciugatura con aria Aplicar Ultra Etch durante 15 segundos Lavar con aire agua durante 5 segundos Secar con aire Aplique Ultra Etch durante 15 segundos Limpe com ar agua durante 5 segundos Seque com ar Ultra Etch under 15 sekunder Tvatta i luft vatten under 5 sekunder Lat lufttorka Ultra Etch i 15 sekunder Skyl med luft vand i 5 sekunder Lufttor Ultra Etch 15 sekuntia llma vesipesu 5 sekuntia llmakuivaa Ultra Etch yia 15 devtepoAenta pe agpa vep yia 5 devtepoAenta XTEYVWOTE ue a pa Gedurende 5 seconden PrimaDry voorzichtig met lucht drogen Verbetert de afdichting duidelijk PrimaDry 5 secondi asciugatura delicata con aria Migliora considerevolmente il sigillo Aplicar PrimaDry durante 5 segundos secar con aire suavemente jMejora el sellado notablemente Aplique PrimaDry durante 5 segundos seque suavemente com ar Intensifica significativamente a selagem PrimaDry under 5 sekunder lufttorka varsamt Forbattrar tatningen avsevart PrimaDry i 5 sekunder lufttor forsigtigt Dette forbedrer forseglingen betydeligt PrimaDry 5 sekuntia kevyt ilmakuivaus Parantaa tiiviytt huomattavasti PrimaDry yia 5 ZTEYVWOTE ue agpa Evioyvet 0 UltraSeal XT grondig op het oppervlak aanbrengen e
27. erial Drying and Priming Agent South Jordan Utah 84095 USA U id Emergency 1 800 552 5512 or 1 801 572 4200 Outside USA Contact Date September 2 1997 EC Representative Prepared by Steve Jensen Chemist SECTION II COMPOSITION INFORMATION ON INGREDIENTS gt Approximate LDso LCso Active Ingredients Concentration 96 Specify Species and Route C A S N A or U N Numbers Ethyl Alcohol 99 LD 7500mg kg Oral Mouse LC o 39g m 3 4H Inhalation Mouse no toxic effect noted SECTION Ill HAZARDS IDENTIFICATION Adverse Human Ethanol ingested in large volumes can be toxic Effects and Symptoms SECTION IV FIRST AID MEASURES A Te lo MM Wash with soap and water Ingestion Give large amounts of water or milk SECTION V FIRE FIGHTING MEASURES Flammability If Yes Under Yes V No Which Conditions Means of Extinction Exposure to spark flame or heat Dry chemical water spray ME Standard protection ECTION VI ACCIDENTAL RELEASE MEASURE SECTION VII HANDLING AND STORAGE Personal amp Environmental Not defined Handling Not defined Precautions Precautions Wipe up with paper towel or cloth Storage Store at room temperature Methods for Cleaning Requirements Keep out of heat and or direct sunlight SECTION VIII EXPOSURE CONTROLS PERSONAL PROTECTION Respiratory N A Eye Protection Protection Protective eyewear Hand Latex gloves Skin Lab coat
28. etsatgarder Enbart f r professionellt bruk Las bruksanvisningar forsiktighetsatgarder och varuinformationsblad innan behandling p b rjas Anvand endast enligt anvisning Hall produkten borta fran varme och solljus Undvik hudkontakt med resiner Hall behandlingsomradet isolerat fran starka kemikalier Kontrollera att patienten inte ar allergisk mot behandlingsmaterialet Testa att materialet flyter fritt ur sprutans spets innan anvandning intraoralt 8 9 10 1T 12 13 14 Prima dell uso intraorale deve essere verificato il flusso del materiale dalla siringa e dalla punta Non forzare mai gli stantuffi delle siringhe Usare le guaine Ultradent Syringe Covers e o pulire e disinfettare le siringhe dopo ciascun paziente Utilizzare lampade polimerizzatrici convenzionali per tutti i materiali fotopolimerizzabili e fotoattivabili Tutte le punte sono monouso Non provare mai a dispensare Ultra Etch o UltraSeal XT plus con la punta a pennello Black Mini Brush PrimaDry infiammabile Maneggiare con attenzione Per prevenire l evaporazione di materiali volatili quali PrimaDry quando le siringhe non vengono usate rimetterre i cappucci luer lock o tappini TipSoc 8 Nunca empuje con fuerza el mbolo 9 Use las cubiertas para jeringas de Ultradent y o limpie y desinfecte las jeringas entre pacientes 10 Utilice luces de fotocurado corrientes con todos los materiales activados polimerizados con luz 11
29. he end of the Inspiral Brush tip Using a scrubbing motion apply to the deepest anatomy of the fissure The resin is then worked into the fissures with the tip of the fibers The Black Micro FX tip is an alternative delivery tip It is preferable to not place too much resin Light Cure Cure 20 seconds if using a standard curing light 10 seconds if using a high energy light Use a quality Halogen or the quality Ultra Lume LED lights Adjust occlusion Precautions Replace luer lock caps when syringes are not in use or use TipSoc covers All 1 2 ml tips are disposable use one per patient Clean and disinfect 1 2 ml syringes between patients Never attempt to deliver any Ultra Etch or sealant through the Black Mini Brush tip Always twist tips securely onto syringes Use slow steady pressure when expressing materials through brush tips Always check the flow of each material on a mixing pad before intra oral use Never force syringe plungers as this could result in the tip blowing off and an uncontrolled discharge of material If there is resistance to flow replace with a fresh tip and test again 6 Remember that any strong acid such as phosphoric acid can burn and irritate tissues Be careful not to splash into eyes onto mucous membranes skin or any other area Confine to areas being etched only Any other area of exposure should be immediately rinsed thoroughly with water 7 PrimaDry is flammable Handle with care 8 Followi
30. i i aplikatora ko c wki Genel Onlemler llo s Yalnizca profesyonel kullanim igindir 2 Tedaviye baslamadan nce talimatlari nlemleri ve MSDS Malzeme G venlik bilgilerini g zden gecirin Yalnizca belirtildigi gibi kullanin r nleri sicaktan g n ndan uzakta muhafaza edin Recinelerin deri ile temas ndan ka n n Tedavi b lgesinden g cl kimyasal maddeleri uzak tutun Tedavide kullanilan maddelere karg1 hastanin bilinen herhangi bir alerjisi olmad n onaylatin 7 Siringadan maddenin akip akmadigini test edin ve agizdan vermeden nce yana egin a EM p sv Aaa diia ar Giant 8 Ca SB Gua hariad 9 AS ll lal 3 10 255 baal 95 ya arid ad Uw 99 202 1 1 BLA A d dl cla quill 30 99 1 12 Qu AU yo bas 13 Lal isa jd Y quis a 3 gall SY 14 Bata ol FANS 1 Meet SUCH 2 AES coll AAAS FLA SR e weree x Alol HEF 48 A AABAS 0 AA GA LES AL 212 0 HS 0 3 su e Cal s c9 PAHIS HESS FE ARAL 8 SAA Pele YS 7 Al AO CHet aale REA 13 PrimaDryz 0
31. mmability Flammability Flammability Reactivity Health SS Reactivity MSDS Included MSDS Included MSDS Included Shelf Life 24 months Shelf Life 48 months Shelf Life 24 months Health Reactivity Health HAZARD RATING 4 Severe 3 Serious 2 Moderate 1 Slight 0 Minimal Ultradent syringes have an expiration date stamped on the side of the syringe consisting of one letter and three numbers The letter is a lot number used for manufacturing purposes and the three numbers are the expiration date The first two numbers are the month and the third number is the last number of the year U S federal law restricts the sale of this device by or on the order of a dentist Keep out of reach of children Refrigerate if not used on a daily basis For immediate reorder and or complete descriptions of Ultradent s product line refer to Ultradent s catalog or call Toll Free 1 800 552 5512 Outside U S call 801 572 4200 or visit www ultradent com Copyright 2004 Ultradent Products Inc All Rights Reserved U S Patent Nos 4 997 371 5 246 371 5 269 684 and 5 425 641 Other U S and International Patents Granted and Pending ULTRADENT PRODUCTS INC Manufactured by Ultradent Products Inc 505 West 10200 South South Jordan Utah 84095 USA 10907 10 091504
32. n inwerken Gedurende 20 seconden met licht polymeriseren Applicazione UltraSeal XT plus sulla superficie Fotopolimerizzazione 20 secondi Aplicar UltraSeal XT plus en la superficie Curar con luz durante 20 segundos Aplique UltraSeal XT plus na superf cie Fotopolimerize durante 20 segundos Arbeta in UltraSeal XT plus i ytan Lat harda l tt under 20 sekunder Bearbejd UltraSeal XT plus ind i overfladen Lysbehandles i 20 sekunder Tyosta UltraSeal XT plus pintaan Valokoveta 20 sekuntia Enetepyaoteite TO UltraSeal XT plus ETIP VELA yta 20 devtepoAemta q t C Fissure Prep Oczysci powierzchni szkliwa uzywajac wiertla Fissure Prep Bur abrazji powietrznej itp Catlak Hazirlama Matkap Ucu hava asindirma vs gibi yontemleri kullanarak mineyi yenileyin oss dados dL Jy e lt la d 00 Fissure Prep Bur 221 ei Of SS ol HE 2H Fissure Prep Bur IWE F S Fo Fissure Prep Bur E
33. ng evaporation of PrimaDry a slight residue will remain This will re dissolve should more PrimaDry by applied To prevent drying of volatile materials such as PrimaDry a TipSoc can be applied 9 Any resin can be sensitizing to the patient Do not use on patients with known sensitivity allergy to resins Wash exposed area completely to remove material If dermatitis rash or any other allergic reaction is observed consult a physician HE IL 1 Lee J Microleakage of New Light Cured Sealants Practical Periodontics and Aesthetic Dentistry Supplement No 1 pp 19 23 June July 1995 Gene L Dickinson D D S M S Microleakage Evaluation of UltraSeal XT Pit and Fissure Sealant with PrimaDry Drying Agent Medical College of Georgia December 8 1992 Available upon request 3 Studies two examples below and clinical experience show that quality of light varies from manufacturer to manufacturer Important Effectiveness of light and light conducting fibers tubes etc decreases as unit ages Light cure units should be checked to be sure that maximum light is being delivered for proper curing Lower intensity lights may require additional curing time Check with a curing radiometer A Dugan William T and Hartleb John H Influence of a Glutaraldehyde Disinfecting Solution On Curing Light Effectiveness General Dentistry 37 40 43 1989 3 B Clinical Research Associates Newsletter 12 3 February 1988 DE Fissurenversi
34. odig Overtuig u ervan dat de pati nt niet allergisch is voor de toegepaste materialen Oo P N Oefen nooit overmatige kracht uit bij de spuitjes Confirm that patient has no known allergies to treatment materials Test flow of materials from syringe and tip before using intraorally Test het functioneren van spuitjes alvorens intra oraal te gebruiken 9 Use Ultradent Syringe Covers and or clean and disinfect syringes between patients 10 Use standard curing lights with all light polymerized activated materials 11 All tips are disposable 12 Never attempt to deliver Ultra Etch or UltraSeal XT plus through the Black Mini Brush tip 13 PrimaDry is flammable Handle with care 14 To prevent drying of volatile materials such as PrimaDry replace luer lock caps when syringes are not in use or use TipSoc covers 8 Dr cken Sie einen Spritzenstempel nie mit Gewalt ein 9 Verwenden Sie Ultradent Spritzenh llen und oder reinigen und desinfizieren Sie die Spritzen nach jedem Patienten 10 Verwenden Sie f r Materialien die durch Licht zu polymerisieren bzw zu aktivieren sind die blichen Polymerisationslampen 11 Alle Ans tze sind f r den Einmalgebrauch 12 Versuchen Sie nie Ultra Etch oder UltraSeal XT plus durch einen Black Mini B rstenansatz zu pressen 13 PrimaDry ist brennbar Mit Vorsicht behandeln 14 Um das Verdunsten leichtfl chtiger Materialien wie PrimaDry zu vermeiden ver
35. opvAdaEeic MSDS amp ektvrjoe ve 0 0 7 5 0710 0 ue npoi vta trjv kOsor n ak goc oe trjv 0 pnrivn ue Epa IIeptoptote trjv ETAPN LOXUPWV xNpLKOV vo nepioxh Bepaneiac Na empefarwoete Ott o 00 6 Sev Exel 6 aAAepytkr avtidpaon 7 Na 6 6818 VALK V obpryya kat TO TIPLV XPNOLLOTOMOETE 06 l 2 ES S
36. schlieBen Sie die Spritze mit der Luer Lock Kappe oder verwenden Sie TipSoc H llen wenn sie nicht im Gebrauch sind 9 Utiliser les couvre seringues Ultradent et ou nettoyer et d sinfecter les seringues apr s utilisation 10 Utiliser une lampe photopolym riser standard avec les mat riaux photopolym risables ou photoactivables 11 Tous les embouts sont jetables 12 Ne jamais tenter d appliquer Ultra Etch ou UltraSeal XT plus via une pointe Black Mini Brush 13 PrimaDry est inflammable Manipuler avec pr cautions 14 Pour viter le s chage des produits volatiles comme PrimaDry replacer le bouchon Luer lock quand les seringues ne sont pas utilis es ou utiliser des capuchons TipSoc 9 Gebruik Ultradent Syringe Covers en of schone spuitjes bij elke pati nt 10 Gebruik steeds geteste lichtuithardingsapparaten 11 Alle tips zijn disposable 12 Ultra Etch of Ultra Seal XT plus nooit met de zwarte Mini Brush tip aan proberen te brengen 13 PrimaDry is brandbaar Voorzichtig hanteren 14 Om uitdroging van vluchtige materialen zoals PrimaDry te voorkomen luer lock dopjes terugplaatsen als de spuiten niet worden gebruikt of TipSoc afdekkingen gebruiken Precauzioni Generali 1 2 Prodotto riservato all uso professionale Prima di iniziare il trattamento vanno esaminate le istruzioni le precauzioni d uso ed i moduli per la sicurezza dei prodotti MSDS Utilizzare esclusivamente nei modi indicati
37. utorna inte anv nds eller anvanda TipSoc f rslutningar lt gt Ge lt lt 9 nerelle forholdsregler 1 Kun til professionelt brug 2 O N Lees vejledningen forholdsreglerne og sikkerhedsdatabladet for behandlingens start Bor kun anvendes som foreskrevet Udseet ikke produktet for varme og sollys Undga hudkontakt med resiner Isoler st rke kemikalier til behandlingsomradet Fa bekreeftet at patienten ikke har kendte allergier mod de produkter der anvendes ved behandlingen Check at materialet flyder frit fra spr jte og spids for brug intraoralt Undlad at bruge voldsom kraft til at tvinge et stempel i funktion Hvis stemplet ikke glider uhindret b r rsagen udredes f rst ohjeet en al ES Vain ammattik ytt n Tutustu k ytt ohjeisiin suojaustoimenpiteisiin ja kayttoturvallisuustiedotteeseen ennen toimenpiteen aloittamista Kayta ainoastaan ohjeiden mukaisesti S ilyt tuote lammolta ja auringonvalolta suojattuna V lt ihokosketusta resiinin kanssa Erist k sitelt v alue vahvoista kemikaaleista Varmista ett potilaalla ei ole todettuja allergioita hoitotoimenpiteess k ytett ville aineille Testaa materiaalin juoksevuus ruiskusta ja k rjest ennen materiaalin k ytt intraoraalisesti IIPODYAASEID 1 2 xpnon u vo 06nyiec mp
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