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

    LARES HANDPIECE OIL

    K Number: K801535 · Decision Dec 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    6
    Review Days
    166

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    Basic Information

    Device Name
    LARES HANDPIECE OIL
    K Number
    K801535
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Lares Manufacturing Co., Inc.
    Date Received
    July 3, 1980
    Decision Date
    December 16, 1980
    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 Lares Manufacturing Co., Inc.

    K Number Device Name
    K831351 PERMALUX VISIBLE CURE COMPOSITE RESTOR
    K801592 FIBER OPTIC HOSE
    K801591 FIBER OPTIC ILLUMINATOR
    K801534 LARES AIR PRESSURE GAUGE
    K780038 DENTAL HANDPIECE