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

    PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT

    K Number: K854882 · Decision Jan 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    130
    Applicant Total
    29
    Review Days
    55

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    Basic Information

    Device Name
    PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT
    K Number
    K854882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3765
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Lee Pharmaceuticals
    Date Received
    December 6, 1985
    Decision Date
    January 30, 1986
    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 Lee Pharmaceuticals

    K Number Device Name
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    K894315 RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT
    K881903 PROSTHODENT VL
    K873123 LEE COMPOSITE INLAY SYSTEM
    K863157 RESTODENT POSTERIOR
    K844133 CLEANSE N BOND I
    K844134 CLEANSE N BOND II
    K843363 RESTODENT VL
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