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510(k) Data Aggregation

    K Number
    K063010
    Device Name
    REGEN BIOCEMENT
    Manufacturer
    STEINER LABORATORIES
    Date Cleared
    2006-11-28

    (57 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    REGEN BIOCEMENT is intended to be used as a bone grafting material in the maxillofacial region.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "REGEN BIOCEMENT," indicated for use as a bone grafting material in the maxillofacial region.

    This document does not contain any information regarding:

    • Acceptance criteria and reported device performance.
    • Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for any test or training sets.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • Types of ground truth used.

    The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed study results on the device's performance against specific acceptance criteria. The letter confirms that the FDA has determined the device is substantially equivalent to a predicate, allowing it to be marketed.

    Therefore, I cannot provide the requested information based on the provided text.

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