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

    CUSTOM COMFORT NIGHTGUARD VERSION 2

    K Number: K091660 · Decision Jun 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    44
    Applicant Total
    8
    Review Days
    3

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    Basic Information

    Device Name
    CUSTOM COMFORT NIGHTGUARD VERSION 2
    K Number
    K091660
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Den Tek Oral Care, Inc.
    Date Received
    June 9, 2009
    Decision Date
    June 12, 2009
    Product Code
    OBR
    Advisory Committee
    Unknown
    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
    OBR Mouthguard, Over-The-Counter

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    Other Clearances by Den Tek Oral Care, Inc.

    K Number Device Name
    K151149 Ready-Fit
    K130186 DENTEK EASY BRUSH WITH FLUORIDE
    K123849 NEW COMFORT-FIT DENTAL GUARD
    K083400 CUSTOM COMFORT NIGHTGUARD
    K081669 IMPROVED COMFORT-FIT NIGHTGUARD
    K072147 DEN TEK COMFORT FIT NIGHTGUARD
    K063483 DEN TEK NIGHTGUARD