BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE

    K Number: K103157 · Decision Jan 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    72
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE
    K Number
    K103157
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Angstrom Mfg., Inc.
    Date Received
    October 26, 2010
    Decision Date
    January 24, 2011
    Product Code
    EGS
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EGS Handpiece, Contra- And Right-Angle Attachment, Dental

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    Other Clearances by Angstrom Mfg., Inc.

    K Number Device Name
    K103158 STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER