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

    PROFICIENT(TM) PROPHYLAXIS ANGLE

    K Number: K881974 · Decision Jul 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    10
    Review Days
    75

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    Basic Information

    Device Name
    PROFICIENT(TM) PROPHYLAXIS ANGLE
    K Number
    K881974
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Block Drug Company, Inc.
    Date Received
    May 11, 1988
    Decision Date
    July 25, 1988
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

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    Other Clearances by Block Drug Company, Inc.

    K Number Device Name
    K945462 SUPER POLI-GRIP DENTURE ADHESIVE CREAM
    K935925 VISION PROPHY PASTE WITH FLUORIDE
    K933893 VISION PROPHY PASTE WITHOUT FLUORIDE
    K884533 SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM
    K872225 SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER
    K862876 NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM
    K800831 PY-CO-PROX TM DENTAL BRUSH
    K791064 DUO TWO LAYER DENTURE CLEANSER
    K780849 DENTROL LIQUID DENTURE ADHESIVE