BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DentureID Microchip

    K Number: K170423 · Decision Oct 25, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    7
    Review Days
    254

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DentureID Microchip
    K Number
    K170423
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6300
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cmp Industries, LLC
    Date Received
    February 13, 2017
    Decision Date
    October 25, 2017
    Product Code
    PYQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PYQ Rfid Chip For Dental Appliance

    Other Clearances by Cmp Industries, LLC

    K Number Device Name
    K170375 Nobilplast Denture Resin
    K072851 POLYSTAR 79 DENTURE BASE RESIN
    K072402 FLEX-STAR V
    K033020 IMPAK ACRYLIC REPAIR RESIN LIQUID
    K953594 VULCAN
    K902972 FLEXOR (DENTURE ACRYLIC RELINE MATERIAL)