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510(k) Data Aggregation

    K Number
    K230091
    Device Name
    THE Cover
    Manufacturer
    Purgo Biologics Inc.
    Date Cleared
    2023-10-06

    (267 days)

    Product Code
    NPL
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K192042
    Why did this record match?
    Device Name :

    THE Cover

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

    THE Cover is recommended for:

    • Covering of immediate or delayed extraction socket to enhance preservation of the alveolar ridge.
    Device Description

    THE Cover Resorbable Collagen Membrane is a white, pliable membrane consisting of fibrous collagen matrix purified from porcine tendon. THE Cover act as a barrier between the gingival and the new bone that can facilitate proper bone regeneration. As soft tissues tend to grow faster than the bone can regenerate, the membrane can help protect the bone graft particles from this faster growing connective tissue. As collagen membrane will be dissolved, no additional operation is necessary. THE Cover does not have a distinction between face and back.

    AI/ML Overview

    The provided text describes the regulatory clearance of a medical device called "THE Cover" and details the studies conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain information related to an AI/Software as a Medical Device (SaMD) or an algorithm.

    Therefore, I cannot provide an answer to your request as it pertains to AI/SaMD acceptance criteria and studies demonstrating algorithm performance. The document focuses on the physicochemical, mechanical, biocompatibility, and in vivo performance of a physical bone grafting material (collagen membrane), not an AI algorithm.

    If you have a document about an AI/SaMD, please provide it, and I will be happy to answer your questions regarding acceptance criteria and study details.

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