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

    MODEL A15-101

    K Number: K953191 · Decision Sep 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    74

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    Basic Information

    Device Name
    MODEL A15-101
    K Number
    K953191
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4620
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Beaverstate Dental, Inc.
    Date Received
    June 23, 1995
    Decision Date
    September 5, 1995
    Product Code
    EAY
    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
    EAY Light, Fiber Optic, Dental

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    Other Clearances by Beaverstate Dental, Inc.

    K Number Device Name
    K953192 MODEL A15-103