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

    PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES

    K Number: K033449 · Decision Jan 7, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    76
    Applicant Total
    1
    Review Days
    70

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    Basic Information

    Device Name
    PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
    K Number
    K033449
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6030
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Professional Dental Technologies Therapeutics, Inc.
    Date Received
    October 29, 2003
    Decision Date
    January 7, 2004
    Product Code
    EJR
    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
    EJR Agent, Polishing, Abrasive, Oral Cavity

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