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

    CRACK DETECTOR, DEN-MAT

    K Number: K770492 · Decision Mar 21, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    7

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    Basic Information

    Device Name
    CRACK DETECTOR, DEN-MAT
    K Number
    K770492
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6140
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dey-Mat, Inc.
    Date Received
    March 14, 1977
    Decision Date
    March 21, 1977
    Product Code
    EFH
    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
    EFH Paper, Articulation

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