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510(k) Data Aggregation

    K Number
    K211872
    Device Name
    PiezoImplant System
    Manufacturer
    Date Cleared
    2022-10-12

    (482 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Product Code :

    NRQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PiezoImplant System is intended for use in dental implant applications for oral rehabilitation of edentulous and partially dentate adult patients over the age of 21 in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The prosthetic components are connected to the implants by the corresponding abutments. The PiezoImplant System is intended for delayed loading.
    Device Description
    The Piezolmplant System consists of endosseous dental implants, surgical instruments and restorative components in a variety of dimensions to accommodate differing patient anatomy. The Rex TL endosseous implants are blade-form having a wedge shape and an endosseous resorbable blast media (RBM) surface. The REX TL 1.8 implant series has a buccolingual thickness of 1.8mm, a mesiodistal width of 5mm and an external hex connection platform. The REX TL 2.9 implant series has a buccolingual thickness of 2.9mm, a mesiodistal width of 5mm and an internal hex connection platform. The endosseous lengths for both implant series range from 9mm to 15mm and all lengths are offered for both series. Cover screws provide protection to the threads of the abutment connection during endosseous and gingival healing. Retention screws fasten the implant and abutment. A variety of Piezolmplant abutments are offered including Healing, Angled, Straight, Provisional Cylinders and Multi-unit. Restorations can be screw and/or cement-retained to the abutments.
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    K Number
    K981954
    Device Name
    VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS
    Date Cleared
    1999-01-25

    (235 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Product Code :

    NRQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The implant(s) is designed for use in the edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed or partial dentures, or a single tooth replacement.
    Device Description
    Various Dental Implants with Various abutments
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