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

    GIROC

    K Number: K951235 · Decision Apr 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    192
    Applicant Total
    8
    Review Days
    31

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    Basic Information

    Device Name
    GIROC
    K Number
    K951235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3750
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Health-Dent Intl., Inc.
    Date Received
    March 20, 1995
    Decision Date
    April 20, 1995
    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 Health-Dent Intl., Inc.

    K Number Device Name
    K972198 DENT-TEMP ACRYLIC
    K953405 HEMA-BENZ
    K951220 HEMA-GLU
    K951381 VILA
    K951380 VILA PC
    K951236 PRO-LOCK
    K951237 ALGI-BAND