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510(k) Data Aggregation

    K Number
    K052574
    Device Name
    COMPACT PLUS - EXTREME - PERFECT PLUS
    Date Cleared
    2006-07-17

    (301 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    **J.O. SUAREZ **& CIA, LTDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHED operative dental unit is intended to serve as a base for other dental DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANC OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT.
    Device Description
    THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHED operative dental unit is intended to serve as a base for other dental DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANC OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT.
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