BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RCT GEL ROOT CANAL THERAPY GEL

    K Number: K972234 · Decision Jun 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    15
    Applicant Total
    279
    Review Days
    14

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    Basic Information

    Device Name
    RCT GEL ROOT CANAL THERAPY GEL
    K Number
    K972234
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentsply Intl.
    Date Received
    June 16, 1997
    Decision Date
    June 30, 1997
    Product Code
    EIC
    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
    EIC Syringe, Periodontic, Endodontic, Irrigating

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