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510(k) Data Aggregation

    K Number
    K984128
    Device Name
    ENIGMA DENTURE TEETH
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    1999-02-09

    (83 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENIGMA DENTURE TEETH

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

    ENIGMA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

    Device Description

    Schottlander ENIGMA denture teeth

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "Enigma Denture Teeth" and does not contain the detailed information required to describe acceptance criteria and a study proving device adherence to these criteria. The document acknowledges FDA's review and determination of substantial equivalence to a predicate device, allowing the product to be marketed.

    To answer your request, I would need a document that includes sections on:

    • Performance testing results
    • Acceptance criteria definitions
    • Methodology of studies (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods)
    • Results of standalone device performance or comparative effectiveness studies.

    The provided text focuses on regulatory clearance and indications for use, not the technical study details you are asking for.

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