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

    DENTAL INSTRUMENTS SCALER

    K Number: K931330 · Decision Jan 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    213
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    316

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    Basic Information

    Device Name
    DENTAL INSTRUMENTS SCALER
    K Number
    K931330
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Minnesota Prophy Power, Inc.
    Date Received
    March 16, 1993
    Decision Date
    January 26, 1994
    Product Code
    EMN
    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
    EMN Scaler, Periodontic

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    Other Clearances by Minnesota Prophy Power, Inc.

    K Number Device Name
    K931329 DENTAL INSTRUMENTS CURETTE PERIODONTAL