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    K Number
    K163640
    Device Name
    QZA and RS Dental Implant Systems
    Date Cleared
    2017-05-03

    (131 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINON Titanium GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TRINON Titanium QZA and RS Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacement to restore patient esthetics and chewing function. TRINON Titanium QZA and RS Dental Implants are indicated for single or multiple unit restorations in non-splinted applications. This can be achieved by a 2-stage surgical technique in combination with delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. TRINON Titanium QZA Dental Implants with a diameter of 3.3 mm may only be used in the upper jaw as a single tooth replacement of the lateral incisors and in the lower jaw as a single tooth replacement of the lateral and central incisors. TRINON QZA and RS abutments are used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. QZA abutment models with an angulation of 30° are indicated for multi-unit loading, such as bridges or overdentures.
    Device Description
    TRINON Titanium QZA Dental Implants are made of titanium grade 5. These are two-stage implants. They have a hexagonal internal cone connection and a spiralock internal thread design. Furthermore, QZA Dental Implants have micro threads in cortical part. TRINON Titanium QZA Dental Abutments are also called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct QZA Dental Implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedures in the IFU. The RS Implants are made of titanium Grade 5. The RS Dental Implants are two-stage implants and are available in 4 diameters for ideal implant selection and four easily identifiable platforms for efficient prosthetic restoration (color-coding). All diameters are available in lengths of 8.5 mm, 10 mm, 11.5 mm, 14.5 mm and 16 mm. The RS Dental Implants have a conical hexagonal interlock. The RS Dental Implants are selftapping high torque arrow-shaped implants with counterclockwise self-tapping function. RS Dental implants have micro threads in cortical part of the implant feature. The RS Abutments are made of titanium Grade 5. These are usually called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct RS dental implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedure descripted in the IFU.
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    K Number
    K103577
    Device Name
    TRINON Q & Q3 IMPLANT SYSTEM
    Date Cleared
    2012-07-03

    (575 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINON TITANIUM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Trinon Q & Q3 Implant System is indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Trinon Q & Q3 Implant System might be loaded in the anterior mandibular arch if four are splinted together with a bar.
    Device Description
    This low-cost implant system was developed to cover many indications in implant dentistry. Designed to provide simplicity and clarity, TRINON TITANIUM GmbH has created a system that removes many of the disadvantages of earlier implant systems. This single-phase enossal implant is made of titanium and there are no complex components. Its self-cutting thread allows the immediate placement of a temporary crown. The transgingival healing makes a second operation unnecessary. The application areas are telescopic and conical crowns, crowns and bridges, and ball attachment restorations. Our one-piece implant system line is divided into the Q-implant system and the Q3 implant-system. The top of the Q-implant system was designed with a 7° cone, whereas the Q3-implant sytem is a one-phase implant with a ballpoint-head. The TRINON Q- and Q³ Implants and its components are available in the lengths 8, 10, 12 and 14mm and diameters 3.5 and 4.5mm.
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