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    K Number
    K103585
    Device Name
    BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2011-03-04

    (87 days)

    Product Code
    EMA,EBF
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP

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

    Bosworth AEGIS Liner & Restorative Material is used as a light-cured radio-opaque cavity liner and pulp capping material, and, with the addition of tooth shades, as a class V restorative material.

    Device Description

    AEGIS Liner & Restorative Material w/ACP

    AI/ML Overview

    The provided text is a Section 510(k) premarket notification determination letter from the FDA for a dental device, "AEGIS Liner & Restorative Material w/ACP."

    This document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria.

    The letter's purpose is to inform the manufacturer that the FDA has reviewed their submission and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their original 510(k) submission, which would have included performance data, but that data is not present in this FDA letter.

    Therefore, I cannot answer any of the specific questions about acceptance criteria or study details as they are not described in the provided text.

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