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510(k) Data Aggregation

    K Number
    K172398
    Device Name
    DENTCA DENTURE Teeth
    Manufacturer
    DENTCA, INC.
    Date Cleared
    2017-11-22

    (106 days)

    Product Code
    PZY
    Regulation Number
    872.3590
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    PZY

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

    DENTCA Denture Teeth is a light-curable polymerizable resin to fabricate, by additive manufacturing, preformed denture teeth to be used in a denture.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Dentca, Inc. regarding their DENTCA DENTURE Teeth. This document is a regulatory approval letter and does not contain information about acceptance criteria, device performance, or study details like sample sizes, ground truth, or expert qualifications.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text.

    The document primarily states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. It also lists the Indications for Use for the DENTCA DENTURE Teeth.

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