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1. Manual Duraplant 2 2 The instruments are laser inscribed with the following information drill and length die and length countersink 1 Description of the implants Duraplant 2 2 two phase implant The anatomically shaped implant is equipped with a self shaping thread but can also be processed with a pre cut thread Duraplant 2 2 implants are available in the following variations REF Article description 13209 Duraplant 2 2 Implant D 3 2 L 9 0 13210 Duraplant 2 2 Implant D 3 2 L 10 5 13212 Duraplant 2 2 Implant D 3 2 L 12 13213 Duraplant 2 2 Implant D 3 2 L 13 5 13215 Duraplant 2 2 Implant D 3 2 L 15 13309 Duraplant 2 2 Implant D 3 6 L 9 0 13310 Duraplant 2 2 Implant D 3 6 L 10 5 13312 Duraplant 2 2 Implant D 3 6 L 12 13313 Duraplant 2 2 Implant D 3 6 L 13 5 13315 Duraplant 2 2 Implant D 3 6 L 15 13409 Duraplant 2 2 Implant D 4 1 L 9 0 13410 Duraplant 2 2 Implant D 4 1 L 10 5 13412 Duraplant 2 2 Implant D 4 1 L 12 13413 Duraplant 2 2 Implant D 4 1 L 13 5 13415 Duraplant 2 2 Implant D 4 1 L 15 13509 Duraplant 2 2 Implant D 4 6 L 9 0 13510 Duraplant 2 2 Implant D 4 6 L 10 5 13512 Duraplant 2 2 Implant D 4 6 L 12 13513 Duraplant 2 2 Implant D 4 6 L 13 5 13515 Duraplant 2 2 Implant D 4 6 L 15 13609 Duraplant 2 2 Implant D 5 4 L 9 0 13610 Duraplant 2 2 Implant D 5 4 L 10 5 13612 Duraplant 2 2 Implant D 5 4 L 12 13613 Duraplant 2 2 Implant D 5 4 L 13 5 13615 Duraplant 2 2 Implant D 5 4 L 15 2 2 Mat2. DURAPLANT FB 012 MD IFU DURAPLANT 2 2 E Rev 00 30 01 2013 Instruction for use 2 2 1 General information The Duraplant 2 2 Implant System may only be applied by dentists and physician who have absolved the training in implantodontics and possess a sufficient amount of expertise The supra structures may only be manufactured by trained dentists and dental technicians The following instructions are not sufficient for the immediate application of the Implant System As the Duraplant 2 2 implants are part of a total concept only original components and instruments may be utilised in accordance with the instructions and recommendations of the manufacturer The manufacturer rejects any responsible if foreign products are utilised The dentist is responsible to select a suitable implant system for his patient and to apply it expertly It is urgently recommended to have an experienced colleague issue instruction regarding the handling of the Implant System supervision and or participate in a Duraplant 2 2 application training A 2 Overview of Duraplant 2 2 Implant System The Duraplant 2 2 Implant System comprises two phase implants dental tools instruments drills and an OP tray which contains a complete set of instruments structured according to the logic of the process sequence The system is colour coded as follows red 3 2 mm green 3 6 blue 4 1 mm yellow 4 7 mm grey 5 4 mm Please follow FB 013 MD User
3. erials NaturaLLock Implants calcium carbonate solidified pure titanium TIMEDUR with Tice surface or TiWithe surface Instruments calcium carbonate solidified pure titanium TIMEDUR pure titanium stainless steel hardened All parts are suitable for autoclave 3 Application A 3 1 Indications The Duraplant 2 2 implants cover all indications of enossal implants in the upper and lower jaw e Single dental prosthesis e Multiple dental prosthesis e Provision for toothless jaw The prosthetic provision can occur by way of crowns bridges and prostheses The abutment can be prepared for the optimal adaptation to the gum margin Please follow FB 013 MD User Manual Duraplant 2 2 3 2 Contraindications General medical contraindications Conditions or disorders which seem to make a surgical intervention irresponsible do not warrant normal healing question the normal function of the body s immune system or exclude the normal reactivity of the bone Local contraindications peri implant bone wall volume too thin provision with attachments axis correction of provision over 21 required CAVE Periodontal deceases have to be arrested prior to the implantation by way of hygiene and or surgical measures Lack of oral hygiene and lack of patient cooperation are contraindications 4 Side effects and interactions Systemic side effects of titanium implants are not known to date Possible complicatio
4. f the implants The following measures are required to avoid thermal pre preparation trauma reduced revolutions of 500 to 800 rpm utilisation of sharp drills utilisation of Duraplant 2 2 drills only in ascending order of diameters external cooling of drills with sterile sodium chloride solution The normal period of acceptance in the lower jaw is 3 months and in the upper jaw 6 months The implants many only be subjected to load after the expiration of these periods 7 General handling Prior to use all instruments have to be carefully cleaned disinfected and sterilised according to the directives of the Robert Koch Institute Prior to each surgical intervention a maximum germ reduction must be ensured according to the general hygiene regulations for surgical interventions A Please follow FB 006 MD processing instructions Duraplant lt is imperative to prevent the contamination of the implants they should therefore be stored in the sterile packaging until immediately prior to the insertion If the manipulation of the implant is unavoidable the use of titanium tweezers is imperative CAVE The ratchet has to be dismantled in its individual components directly after usage and must be carefully cleaned and disinfected 5 Packaging and sterility The packaging of Duraplant 2 2 implants consists of the non sterile storage packaging including operating instructions the secondary packaging as germ ba
5. ns injury of anatomic structures particularly permanent anaesthesia due to damage of N alveolaris inferior perforation of nasal cavity or maxillary sinus perforation of lingual bone wall chronic pain in chronological context with the implant fractures bone fracture implant or instrument fracture dental prosthesis fracture peri implant inflammations The treating physician or dentist has to be consulted immediately in case of unexpected pain beyond normal postoperative pain or other complications It is known that implants may be rejected or get lost without discernible reasons 5 Preoperative planning General medical examination complete clinical and radiological dental examination education of patient regarding indications contraindications and success ratio education of patient regarding the necessity of regular follow up examinations including the establishment of an oral hygiene schedule which if required includes a periodontal surgical restoration establishment of preoperative and prosthetic overall plan in consultation with the dental technician 6 Surgical technique The systems related surgical technique is imparted in a special Duraplant 2 2 application training A subtle operation technique in hard and soft tissue is imperative in order to ensure optimal conditions for the implant to be accepted CAVE Please consider that the length of cut is up to 1 4 mm longer than the implantation depth o
6. rrier the sterile primary packaging A previously used or non sterile or contaminated Duraplant 2 2 implant may not be implanted under any circumstances T Don t use the implant after damage oft he original package The implant cannot be returned to the manufacturer or distributor in case of damage to the original packaging sree Q Do not re sterilise 9 Storage The originally packaged Duraplant 2 2 implants have to be stored in dry condition at normal room temperature The implants may not be used after the expiration of the sterilisation expiration date 10 Traceability and documentation The implants may be traced based on the article and lot numbers The implants can be traced from the patient back to the manufacturer by way of adhesive labels on the patient passport and in the patient file For forensic reasons the manufacturer recommends the complete clinical radiological photographic and statistic documentation 11 Provision of Duraplant 2 2 implants Duraplant 2 2 implants are exclusively provided to physicians and dentists Participation in training through the distributor is urgently recommended Manufacturer ZL MICRODENT AT TACHMENT GMBH amp CO KG SchutzenstraBe 6 8 58339 Breckerfeld Tel 0 23 38 8010 Fax 0 23 38 801 40 C 0535 Electronical instruction for us C l available at www duraplant de
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