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    K Number
    K970321
    Device Name
    BIO-OSS ANORGANIC BOVINE BONE
    Manufacturer
    GEISTLICH-PHARMA
    Date Cleared
    1998-09-15

    (595 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-OSS ANORGANIC BOVINE BONE

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

    Augmentation or reconstructive treatment of alveolar ridge defects also of any indeasal defects Filling of periodontal defects Filling of defects after root resection, apicoectony, and cyscecomy, and cyscecomy of the also and of and and and and enhance preservarion of- the alveola Filling of defects after root teseccion, approactory, and of the alvestar ridge Elevacion of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Filling of periodontal defects in conjunector aren production (GBR). Guided Tissue Regeneration(GTR) and Guided Bone Regeneration(GBR). villag of peri-implant defects in conjunction with products intended for the before Bear archier/GRP) Guided Bone Regeneration (GBR)

    Device Description

    Anorganic Bovine Bone

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a medical device (Bio-Oss Anorganic Bovine Bone) and discusses its substantial equivalence to a predicate device for marketing purposes. It does not include acceptance criteria, study details, performance metrics, sample sizes, or information about ground truth establishment.

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