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510(k) Data Aggregation

    K Number
    K103158
    Device Name
    STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER
    Manufacturer
    ANGSTROM MFG., INC.
    Date Cleared
    2011-02-07

    (104 days)

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

    ANGSTROM MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This Device is to be used by a Dental Hygienist for cleaning procedures on teeth. For the coupling of Disposable Prophy Angles to Dental Handpiece motors. Prescription Use: Used by dental Professional Only Over the Counter Use: No
    Device Description
    DPA Attachment Twist/Flex Adapter
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    K Number
    K103157
    Device Name
    DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE
    Manufacturer
    ANGSTROM MFG., INC.
    Date Cleared
    2011-01-24

    (90 days)

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

    ANGSTROM MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This Device is to be used by a Dentist or A Dental Hygienist for cleaning procedures on teeth.
    Device Description
    Disposable Prophy Angle
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