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510(k) Data Aggregation

    K Number
    K030195
    Device Name
    BBP BONE SUBSTITUTES
    Manufacturer
    OCT, USA, INC.
    Date Cleared
    2004-06-17

    (513 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

    The BBP™ Bone Substitute is a bone filling augmentation material used for augmentation or reconstruction of the alveolar ridge, filling of periodontal bony defects, and filling of extraction sockets to enhance preservation of alveolar ridge.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "BBP™ Bone Substitute." It does not contain information about acceptance criteria or a study proving its performance.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory aspects like registration, labeling, and manufacturing practices, but does not include any performance data or study details.

    Therefore, I cannot provide the requested information based on the provided text. The document does not describe acceptance criteria, device performance, sample sizes, ground truth establishment, or any information about a study.

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