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

    REST ASSURED READY TO WEAR NITE PROTECTOR

    K Number: K112879 · Decision Jan 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    44
    Applicant Total
    8
    Review Days
    119

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    Basic Information

    Device Name
    REST ASSURED READY TO WEAR NITE PROTECTOR
    K Number
    K112879
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ranir, LLC
    Date Received
    September 30, 2011
    Decision Date
    January 27, 2012
    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 Ranir, LLC

    K Number Device Name
    K133423 REST ASSURED EXTRA COMFORT NITE PROTECTOR
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    K103004 SNORE GUARD
    K102118 SNORE GUARD ADVANCE
    K094020 GRIND NO MORE GENERATION II
    K091175 GRIND NO MORE VERSION 2 AND 3
    K063229 REST ASSURED NITE PROTECTOR