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

    M-PM-DISC

    K Number: K134015 · Decision Apr 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    9
    Review Days
    105

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    Basic Information

    Device Name
    M-PM-DISC
    K Number
    K134015
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merz Dental GmbH
    Date Received
    December 27, 2013
    Decision Date
    April 11, 2014
    Product Code
    MQC
    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
    MQC Mouthguard, Prescription

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    Other Clearances by Merz Dental GmbH

    K Number Device Name
    K173124 PEEK Biosolution
    K140758 M-PM-DISC (PINK)
    K130076 PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS
    K120404 MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
    K080556 ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES
    K071548 WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED
    K061809 ARTEGRAL IMCROWN
    K030588 ARTEGRAL AND POLYSTAR SELECTION