BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇹 Austria

    SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD

    K Number: K984508 · Decision Jun 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    12
    Applicant Total
    18
    Review Days
    189

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    Basic Information

    Device Name
    SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD
    K Number
    K984508
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4130
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    W&H Dentalwerk Buermoos GmbH
    Date Received
    December 18, 1998
    Decision Date
    June 25, 1999
    Product Code
    DZA
    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
    DZA Drill, Dental, Intraoral

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