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510(k) Data Aggregation

    K Number
    K973575
    Device Name
    DURALASTIC ANATOMICAL CHIN IMPLANTS
    Manufacturer
    HANSON MEDICAL, INC.
    Date Cleared
    1997-11-07

    (49 days)

    Product Code
    FWP
    Regulation Number
    878.3550
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K971478
    Predicate For
    K090803
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Duralastic Chin implants are intended for use in augmentation and reconstruction of the chin. They are intended for insertion via an intraoral or submental incision.

    To augment or reconstruct the chin or each and class and currentaun indicacionandibular contour.

    Device Description

    Chin implants are crescent shaped concave convex Duralastic silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562 and Nusil Technologies' MAF 612. The Duralastic Chin Implants will be provided sterile and nonsterile.

    AI/ML Overview

    The provided text describes a 510(k) submission for a chin implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against specific acceptance criteria. Therefore, the information typically required for a medical device performance study (such as acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRI study results) is not present in this document.

    The document primarily covers:

    • Product Description: Materials, physical properties, intended use, and sterilization method of the Duralastic Chin Implants.
    • Substantial Equivalence: States that the Duralastic Chin implants are substantially equivalent (SE) to Allied Biomedical chin implants (K971478).
    • Regulatory Information: A letter from the FDA confirming the finding of substantial equivalence and allowing the device to be marketed.

    Since this is a submission for substantial equivalence based on material properties and comparison to a predicate device, a clinical performance study with specific acceptance criteria as you've outlined is not included or required for this type of submission.

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