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

    PIT AND FISSURE CHEMICAL CURING SEALANT

    K Number: K011822 · Decision Aug 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    130
    Applicant Total
    7
    Review Days
    57

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    Basic Information

    Device Name
    PIT AND FISSURE CHEMICAL CURING SEALANT
    K Number
    K011822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3765
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rite-Dent Manufacturing Corp.
    Date Received
    June 11, 2001
    Decision Date
    August 7, 2001
    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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