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510(k) Data Aggregation

    K Number
    K983547
    Device Name
    PROTECH PLUS
    Manufacturer
    PROTECH, INC.
    Date Cleared
    1999-01-07

    (90 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ProTech's Denture Relining, Repairing/Rebasing Resin is indicated for relining a denture surface that contacts tissue, to repair a fracture denture, or to form a new denture base.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental product. It does not contain information about acceptance criteria or a study proving device performance as typically expected for imaging or AI-based medical devices. The letter is a regulatory document confirming that the device, ProTech Plus Denture Relining, Repairing/Rebasing Resin, is substantially equivalent to legally marketed predicate devices for its stated indications for use.

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

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