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510(k) Data Aggregation

    K Number
    K051224
    Device Name
    BOSWORTH SEAL
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2005-07-28

    (77 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BOSWORTH SEAL

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

    Bosworth Seal is a light-activated dental sealant for sealing pits and fissures of anterior and posterior teeth. The Bosworth Seal is a surface glaze and is used for denture and orthodontic retention systems.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental pit and fissure sealant called "Bosworth Seal." It does not contain information about acceptance criteria, device performance, or any studies. The letter is a regulatory approval, not a scientific report detailing clinical trials or performance evaluations.

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

    To answer your request, I would need a document that describes the clinical performance evaluation of the "Bosworth Seal" device, detailing its testing and results against specified performance metrics.

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