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

    ENAMEL ETCHING GEL

    K Number: K910803 · Decision Mar 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    192
    Applicant Total
    7
    Review Days
    17

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    Basic Information

    Device Name
    ENAMEL ETCHING GEL
    K Number
    K910803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3750
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Gresco Products, Inc.
    Date Received
    February 26, 1991
    Decision Date
    March 15, 1991
    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 Gresco Products, Inc.

    K Number Device Name
    K981524 PRILANE
    K913405 KAR-D-TEK
    K910813 MET-ETCH
    K901973 CP-3 DENTAL POLISHING MATERIAL
    K854495 GRESCO N.P. DENTAL ALLOY
    K854494 CERAM-ETCH