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510(k) Data Aggregation

    K Number
    K190552
    Device Name
    JJ Implant System
    Manufacturer
    JJ Implants
    Date Cleared
    2019-12-06

    (276 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
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    Applicant Name (Manufacturer) :

    JJ Implants

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations for functional and esthetic rehabilitation. JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. JJ Implant System Mini implants may be used for denture stabilization using multiple implants in the anterior mandible and the anterior maxilla, and are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate.
    Device Description
    The JJ Implant System comprises three lines of endosseous root-form dental implants: two lines with an internal hexagonal prosthetic interface (Genesis Normo), mating abutments, abutments, abutment screws, and other associated components; and a line of one-piece, small diameter dental implants (Mini) for retention of overdentures.
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