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

    PAINT-ON-RESTORATIVE W/FISSURE SEALER

    K Number: K800391 · Decision Apr 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    130
    Applicant Total
    5
    Review Days
    50

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    Basic Information

    Device Name
    PAINT-ON-RESTORATIVE W/FISSURE SEALER
    K Number
    K800391
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3765
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    American Dental Research
    Date Received
    February 20, 1980
    Decision Date
    April 10, 1980
    Product Code
    EBC
    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
    EBC Sealant, Pit And Fissure, And Conditioner

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    Other Clearances by American Dental Research

    K Number Device Name
    K800393 POLY SULFIDE IMPRESSION PASTE W/CATALYST
    K800389 ANTERIOR & POST. RESTORATIVE PASTE SYS.
    K800390 ANT. & POST. RESTORATIVE POWDER LIQ.
    K800392 BRACKET BONDING SYSTEM METAL & PLASTIC