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510(k) Data Aggregation

    K Number
    K983285
    Device Name
    ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS
    Date Cleared
    1998-11-04

    (47 days)

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

    ENGLE DENTAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Engle Dental Systems Family of Dental Units are medical devices to be used by dentists, and hygienists in the procedures they perform. The Engle Dental Systems Family of Dental Units feature numerous attachments and suction instruments. The Engle Dental Systems Family of Dental Units utilize foot controls, assistant's arms, and were to taster to the hand pieces that operate demal handpock the dentists use in the procedures they periodi on the stanges as Upits feature numerous attachments and su fion instruments. The Eligie Domar Dyschall foot controls, assistant's arms.
    Device Description
    Dental units
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