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510(k) Data Aggregation

    K Number
    K023953
    Device Name
    ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
    Date Cleared
    2003-02-14

    (79 days)

    Product Code
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ST. GEORGE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a plastic disposable attachment for use in conjunction with a slow speed handpiece, used during the professional prophylaxis treatment of patient's teeth by a dentist or hygienist. Our disposable prophylaxis angle is intended as a single use device used by a Dental Professional, either a Dentist or a Dental Hygienist to assist in the cleaning process of patient's teeth. It is intended for a single patient and should be discarded after each patient.
    Device Description
    Plastic disposable item comprising a housing (body) that holds two plastic shafts aligned at 90 degrees (right angle) to each other that rotate a cup or brush. Plastic one-piece housing (outer body) holding 2 internal shafts aligned at 90 degree (right angle) to each other. Tip fitted with a rubber cup or brush to clean teeth.
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    K Number
    K992176
    Device Name
    EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL
    Date Cleared
    2000-02-10

    (227 days)

    Product Code
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    ST. GEORGE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Excel Ultra-Hi Formula Heat-Cured Denture Base material is indicated for use in the fabrication, repairing, relining and/or rebasing of full or partial removable prosthetic devices.
    Device Description
    Excel Ultra-Hi Formula Heat-Cured Denture Base
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