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510(k) Data Aggregation

    K Number
    K030292
    Device Name
    GROMAN PREPMASTER
    Manufacturer
    GROMAN INC.
    Date Cleared
    2003-04-15

    (77 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GROMAN PREPMASTER

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

    Cutting and Preparation of tooth structure, both enamel and dentin for all classes of cavity preparations. Removal of composite restorations. For roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures.

    Indications for use are identical to Microetcher AP/PrepStar™ by Danville Engineering Inc.

    For Use by Dentists Only.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text only contains an FDA 510(k) clearance letter for the "Groman PrepMaster™" device. This letter primarily focuses on the regulatory approval and substantial equivalence to a predicate device.

    It does not contain any information regarding specific acceptance criteria, study designs, sample sizes, expert qualifications, or performance metrics that would be necessary to answer your questions about the device's performance study.

    Therefore, I cannot provide the requested table or describe the study that proves the device meets acceptance criteria based on the given input.

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