TiBase Operating Instructions
Contents
1. New as of 04 2012 irona The Dental Company Sirona Dental CAD CAM System TiBase Operating Instructions English US This product is covered by one or more of the following US patents e US7901209 Table of contents Sirona Dental Systems GmbH Operating Instructions TiBase Table of contents 1 MVINIDOIS ISOC se5 5 05 T cetera suctaniatats tuvedan dente adadue datete AT 3 2 ProductideSCriptlOnivsccsesctss cent ieekas avid wat e Gast Hee Ih Masai 4 3 Material t renea e a a aA ae nied Gwin eras Sh oeeheovaes 6 4 Indications fOr USC snide aea aE E EEEE A AEEA EENE 7 5 Use of TiBase devices and contra indications cccccccceccccecceecececeeeeeeeeeeeeeeeteees 8 6 PROCESSING MUN Sie aozieecetee statue evade e net Peed a eaa K ia Ea E aE Ese 9 6 1 SCANNING a o ee aa enaar poet dA aaae dle AAEE Ea a a AASR 9 6 2 Processing the TiBase aes cciiccssdvasirncscaducantiaacelenueseceehubaeiveedtaaniiaencediataeeteads 10 6 3 Information for the dentist ccccccccccccccceccecceeeceeeeceeeeeeeeceeeeeeceeeeeeeeeeeeteess 11 GSE SteriliZatlon zin p Bienes vane deeved eiuatt vases E EEA estes 11 6 3 2 Tightening torques i ssesisiriisrisierinicesescerensestrsorrisiunitedrnuuiinnadden e deaan 11 63 33 657 D3568 D3568 201 01 07 23 04 2012 Sirona Dental Systems GmbH Operating Instructions TiBase CE 0123 Rx only ABc123 XXXXXXX N 63 33 657 D3568 D3568 201 01 07 23 04 2012 S2. GmbH Operating Instructions TiBase Use of TiBase devices and contra indications TiBase devices are attached to an implant as prosthetic titanium base for adhesion to mesostructures to restore function and aesthetics in the oral cavity Contra indications are e Insufficient oral hygiene e Insufficient space available e Bruxism e For restorations with angulation correction of more than 20 to the im plant axis e For individual tooth restorations with free end saddle e For restorations whose length exceeds a ratio of 1 1 25 in compari son to the length of the implant 63 33 657 D3568 8 D3568 201 01 07 23 04 2012 Sirona Dental Systems GmbH Operating Instructions TiBase 63 33 657 D3568 D3568 201 01 07 23 04 2012 Processing hints Scanning and designing Processing hints Scanning and designing 1 Mount the TiBase on the matching laboratory analog in the master model and screw it tight using the supplied abutment screw Plug the supplied scanbody onto the TiBase so that it is seated free of gaps and therefore flush while watching out for the intended guide groove The scanbody is scannable without powder or scan spray Acquire the situation alternatively with inEos Blue or CEREC AC Use the inLab SW 4 0 or higher to design the individual shape of the mesostructure and mill the shape from an inCoris ZI meso block see inLab SW 4 x User Manual Be sure to observe the information on design postprocessing
3. and sintering of zirconia provided in the Ope rating Instructions for inCoris ZI meso blocks Observe the safety limits during the design The known safety limits of the inCoris ZI meso and the TiBase materials are e Minimum wall thickness 0 5 mm Maximum angle 20 Exceeding specified safety limits of your device results in the construction of a misbranded device which may lead to premature abutment fracture In this case the patient must be informed that he is going to receive a device that is beyond the labeled specifications 10 Processing the TiBase The diameter of the TiBase must not be reduced e g by grinding Shor tening the TiBase is not recommended The contact surfaces of the TiBase to the implant should not be sand bla sted or otherwise processed Only the surfaces of the TiBase intended for gluing with a mesostructure must be sandblasted 50um aluminum oxide max 2 0 bar and then clea ned with alcohol or steam The TiBase should be fastened in a labora tory analog to protect the internal connection Use PANAVIA F 2 0 www kuraray dental de as an adhesive extra orally to connect the TiBase and the sintered inCoris ZI mesostructure 1 For easier handling during the gluing process it is recommended that the TiBase be screwed into a lab implant or a polishing tool 2 Cover the hex head of the abutment screw with wax 3 Mix the glue according to the manufacturer s instructions and a
4. is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible The system consists of three major parts TiBase inCoris mesostructure and CAD CAM software Specifically the inCoris mesostructure and TiBase components make up a two piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD CAM types K2244_xxxx K083496 in the Camlog Implant System The CAD CAM software is intended to design and fabricate the inCoris mesostructure The inCoris mesostructure and TiBase two piece abutment is compatible with the following implants systems e Nobel Biocare Replace K020646 e Nobel Biocare Branemark KO22562 e Friadent Xive K013867 e Biomet 3i Osseotite K980549 e Astra Tech Osseospeed K091239 e Zimmer Tapered Screw Vent K061410 e Straumann SynOcta K061176 e Straumann Bone Level K053088 K062129 K060958 e Biomet 3i Certain K014235 K061629 e Nobel Biocare Active K071370 Small diameter implants and large angled abutments in the anterior region of the mouth due to possible failure of the implant system Federal Law USA restricts sale of this device to or on the order of a physician dentist or licensed practitioner Use of TiBase devices and contra indications Sirona Dental Systems
5. me is 5 minutes at 134 C 273 2 F and 15 minutes at 121 C 249 8 F Steam sterilization may be performed only using devices that comply with EN 13060 or EN 285 standards It must be ensured that only suitable devices are used to perform sterili zation The fabricator dental technician of the TiBase and the mesostructure must inform the dentist of the need to sterilize the abutment before inser ting it in the patient s mouth Tightening torques Use the tools provided by the implant manufacturer to screw the restora tion onto the implant observing the tightening torques specified in the fol lowing table TiBase Tightening torque in Nem NBRS 35 NBB 35 SSO 35 ATOS 25 FX 25 BO 35 ZTSV 30 BC 20 S BL 35 NB A NP 25 NB ARP 35 63 33 657 D3568 D3568 201 01 07 23 04 2012 11 We reserve the right to make any alterations which may be required due to technical improvements Sirona Dental Systems GmbH 2010 2012 Sprache englisch US Printed in Germany D3568 201 01 07 23 04 2012 A Nr 115590 E E Sirona Dental Systems GmbH in the USA Fabrikstra e 31 Sirona Dental Systems LLC Order No 63 33 657 D3568 64625 Bensheim 4835 Sirona Drive Suite 100 Germany Charlotte NC 28273 Www sirona com USA
6. pace 60 feom nce reso pesa wa feaa OO Sornos 2751 rm nc reso enso e fi fems __ _ nobotacer farson incosz meso soss m fe femmo eeen fiamm incorsz nesot 55065 m fi fems O een fes _ ncos meso smar ms i femer femerwerme farraorm inconszimesot mossasojwa L oaasio Jossospees asraon inconszi meo pos me e omaeon Fase fraen foarm iconz mess poe me e foma ranne feom nconszmess pas me i enze ranns fsm ncn 1 meso pes me oaze rran fsm incom reso aoa a fe femes ere fiam nc meso eosa a _ easasra ere o feom roosa rea eca ms i femer Joonan atm inconszimeso1 Boso we i leom orane eom nce meot zevas me i femre ree crew ven 4mm ncn meso svor wis i sacar rere 7 wn romea reot e letter S and L identities the connection geometry with respect to the titanium bases 63 33 657 D3568 D3568 201 01 07 23 04 2012 5 Materials Sirona Dental Systems GmbH Operating Instructions TiBase Materials TiBase abutment screw TI6AI4V medical grade 5 ASTM 136 Scanbody ABS Cycolac GPM 5500 WH4A015F 63 33 657 D3568 6 D3568 201 01 07 23 04 2012 63 33 657 D3568 D3568 201 01 07 23 04 2012 Indications for use The Sirona Dental CAD CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple unit cement retained restorations For the titanium bases SSO 3 5 L and SBL 3 3 L the indication
7. pply it to the TiBase 4 Push the sintered inCoris ZI mesostructure in as far as it will go Make sure it latches into the rotation and position stops 5 Remove excess glue immediately 6 Apply the Airblocker Oxyguard to the junction where the ceramic and titanium surfaces meet and to the screw funnel for final harde ning 7 Remove residue with a rubber polisher after hardening The fixture to the abutment connection is essential to the mechanical stability of the dental implant system Any modification to this connection qualifies as a change to a Class II medical device and qualifies the creator as a medical device manufacturing facility Any change to this connection will characterize your facility as a medical device manufacturer subject to FDA registration fees regulation and restrictions 63 33 657 D3568 D3568 201 01 07 23 04 2012 Information for the dentist The TiBases are delivered in non sterile condition Observe the implant manufacturer s operating instructions Sterilization The individual abutments must be sterilized prior to insertion Furthermo re the locally applicable legal regulations and the hygiene standards ap plicable for a dental practice must be observed Use only the procedures specified below to sterilize individual abutments Observe the sterilization parameters Steam sterilization can be performed with the fractionated vacuum or the gravitation method The sterilization ti
8. ymbols used Symbols used NOTICE Observe Operating Instructions This product is a medical device in accordance with Council Directive 93 42 EEC CAUTION Federal law USA restricts sale of this device to or on the or der of a physician dentist or licensed practitioner Article number Batch number This product is intended for single use only non sterile Product description Sirona Dental Systems GmbH Operating Instructions TiBase Product description Each delivery includes a TiBase the titanium base from Sirona an abut ment screw and a scanbody in non sterile form All parts are intended for single use only Individually manufactured mesostructures or provisional restorations can be glued onto the TiBase The glued parts are screwed onto the matching implant with the abutment screw in the patient s mouth The scanbody is used only to scan the position of the implant for creating the design in the inLab SW 4 x software 63 33 657 D3568 4 D3568 201 01 07 23 04 2012 Sirona Dental Systems GmbH Product description Operating Instructions TiBase The Sirona TiBase comes in various versions each of which is compatib le with a specific diameter of a specific implant system Product compatible with implant system compatible with grinding blocks Ee ee screw body manufacturer diameter ersa wa fe femre repasse am incon meso ersso m fe onze reniee wwe feom finconszmeso ers 60 w i _ oasason re
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