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

    PRIME-DENT HEMA DESENSITIZER

    K Number: K013970 · Decision Feb 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    9
    Review Days
    78

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    Basic Information

    Device Name
    PRIME-DENT HEMA DESENSITIZER
    K Number
    K013970
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Prime Dental Manufacturing, Inc.
    Date Received
    December 3, 2001
    Decision Date
    February 19, 2002
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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    K012794 PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
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    K012673 PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
    K001108 PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
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