LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033098
    Device Name
    OSTEOGEN SBRG
    Manufacturer
    IMPLADENT, LTD.
    Date Cleared
    2004-04-27

    (211 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K033044
    Why did this record match?
    Device Name :

    OSTEOGEN SBRG

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

    As an aid in sinus augmentation (sinus lift) procedures.

    As an aid in the augmentation of tooth sockets and the treatment of alveolar ridge deformities, including peri-implant alveolar defects.

    As an aid in the treatment of periapical and periodontal defects.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text does not contain information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the OsteoGen® (SBRG) device, indicating that it has been found substantially equivalent to a legally marketed predicate device.

    The content focuses on regulatory information, the device's indications for use, and contact details for the FDA. There is no mention of:

    • A table of acceptance criteria or reported device performance.
    • Sample sizes for test sets or data provenance.
    • Number or qualifications of experts for ground truth.
    • Adjudication methods.
    • MRMC comparative effectiveness studies or effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used (e.g., pathology, outcomes data).
    • Sample size for training sets.
    • How ground truth for training sets was established.

    Therefore, I cannot fulfill your request based on the input provided.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1