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

    FIBER OPTIC HANDPIECE

    K Number: K780483 · Decision Apr 28, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    10
    Review Days
    32

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    Basic Information

    Device Name
    FIBER OPTIC HANDPIECE
    K Number
    K780483
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Syntex Corp.
    Date Received
    March 27, 1978
    Decision Date
    April 28, 1978
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

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    K780769 S-100 CT SCANNER
    K761331 OPUS I OPTION - FIBER OPTIC L SYSTEM
    K761332 HI-SENSITIVITY MODE OPTION FOR S60-1A
    K761330 SYNTEX SYSTEM 6000
    K761264 OPTIONS FOR STAR DENTAL OPUS I
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