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510(k) Data Aggregation

    K Number
    K983558
    Device Name
    ACETAL DENTAL/PREFORMED CLASP
    Manufacturer
    DENTAMAX, INC.
    Date Cleared
    1999-01-07

    (86 days)

    Product Code
    EHP,OCT
    Regulation Number
    872.3285
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACETAL DENTAL/PREFORMED CLASP

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

    Fabrication of dental prostheses like: clasps on partial prostheses, provisional bridges, space maintainers, partials, active and passive aesthetic containing devices, and gnatological bites.

    Device Description

    Acetal Dental / Preformed Clasp

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device (Acetal/Dental Preformed Clasp). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

    Therefore, I cannot provide the requested information based on the provided text. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It details regulatory information and responsibilities but not the technical data supporting the clearance.

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