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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    GROMAN INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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