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

    PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

    K Number: K012673 · Decision Oct 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    192
    Applicant Total
    9
    Review Days
    71

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    Basic Information

    Device Name
    PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
    K Number
    K012673
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3750
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Prime Dental Manufacturing, Inc.
    Date Received
    August 14, 2001
    Decision Date
    October 24, 2001
    Product Code
    DYH
    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
    DYH Adhesive, Bracket And Tooth Conditioner, Resin

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    Other Clearances by Prime Dental Manufacturing, Inc.

    K Number Device Name
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    K013970 PRIME-DENT HEMA DESENSITIZER
    K012794 PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
    K012761 PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
    K001108 PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
    K994224 PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL