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

    PROPHY CUPS, R&R

    K Number: K780198 · Decision Feb 16, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    7
    Applicant Total
    7
    Review Days
    9

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    Basic Information

    Device Name
    PROPHY CUPS, R&R
    K Number
    K780198
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6290
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Ransom and Randolph
    Date Received
    February 7, 1978
    Decision Date
    February 16, 1978
    Product Code
    EHK
    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
    EHK Cup, Prophylaxis

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    K770598 ENDODONTIC INSTRUMENTS, R&R CUTWELL
    K761067 DENTSPLY DIE STONE