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

    QAR HANDPIECE

    K Number: K904671 · Decision Dec 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    9
    Review Days
    70

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    Basic Information

    Device Name
    QAR HANDPIECE
    K Number
    K904671
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Collagen Corp.
    Date Received
    October 12, 1990
    Decision Date
    December 21, 1990
    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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    Other Clearances by Collagen Corp.

    K Number Device Name
    K904228 OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)
    K901600 OSSEOTITE IRRIGATION UNIT
    K900275 OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNET
    K895462 OSSEODENT DENTAL ATTACHMENTS
    K895463 OSSEODENT(R) PRECISION DENTAL ATTACHMENTS
    K894331 OSSEODENT SURGICAL KIT
    K883322 DENTAL HAND INSTRUMENTS
    K812617 VITROGEN TM 100