LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974655
    Device Name
    PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM
    Manufacturer
    PREP TECHNOLOGY CORP.
    Date Cleared
    1998-07-09

    (206 days)

    Product Code
    KOJ, DAT
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREP TECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prep Technology Corp. PrepTech 200TM Cavity Preparation System is intended for use in cavity preparation for bonded restorations, the removal of decayed or sound tooth structure and composite restoration materials and for the preparation of tooth surfaces prior to pit and fissure sealant and composite restorations.
    Device Description
    The Prep Technology Corp. PrepTech 200 Cavity Preparation System is a device that combines pressurized air and aluminum oxide powder to produce a high velocity stream of kinetic particles to perform dental restorative procedures, including preparation for pit and fissure sealants and composite restorations.
    Ask a Question

    Page 1 of 1