BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM

    K Number: K884533 · Decision Apr 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    418
    Applicant Total
    10
    Review Days
    166

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    Basic Information

    Device Name
    SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM
    K Number
    K884533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Block Drug Company, Inc.
    Date Received
    October 28, 1988
    Decision Date
    April 12, 1989
    Product Code
    KLE
    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
    KLE Agent, Tooth Bonding, Resin

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    Other Clearances by Block Drug Company, Inc.

    K Number Device Name
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    K881974 PROFICIENT(TM) PROPHYLAXIS ANGLE
    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