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510(k) Data Aggregation

    K Number
    K051091
    Device Name
    SYNTHOGRAFT
    Manufacturer
    Date Cleared
    2005-09-01

    (126 days)

    Product Code
    Regulation Number
    872.3930
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHOGRAFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synthograft is designed for:

    • the filling and or reconstruction of either traumatic or degenerative multi-wall bone defects
    • the augmentation of the sinus floor
    • the augmentation of the alveolar ridges
    • the augmentation of the alveblar hagos
    • the filling of periodontal or other alveolar bone defects and tooth sockets and osteotomies
    • the preservation of the alveolus for the preparation of an implant site.
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) substantial equivalence letter for a device named "Synthograft," a bone grafting material. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria, as it is a regulatory clearance document rather than a performance study report.

    Therefore, I cannot provide a response filling in the requested information as the source text does not contain such details. The document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and outlines regulatory conditions for marketing.

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