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510(k) Data Aggregation

    K Number
    K970569
    Device Name
    BIO-BLOCKS
    Manufacturer
    GEISTLICH-PHARMA
    Date Cleared
    2000-08-14

    (1294 days)

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

    BIO-BLOCKS

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

    Augmentation of reconstructive treatment of the alveolar ridge

    Filling of defects after root resection, apicoeccomy and cystectomy

    Filling of extraction sockets to enhance preservation of the alveolar ridge

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for Bio-Oss® Blocks. It confirms that the device is substantially equivalent to a legally marketed predicate device. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details about a study to prove the device meets acceptance criteria.

    The letter focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report.

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