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

    TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE

    K Number: K973062 · Decision Oct 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    52

    Basic Information

    Device Name
    TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE
    K Number
    K973062
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MEDIDENTA INTL., INC.
    Date Received
    August 18, 1997
    Decision Date
    October 9, 1997
    Product Code
    EFA
    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
    EFA Handpiece, Belt And/Or Gear Driven, Dental

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