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

    Resolve 2.0

    K Number: K152322 · Decision Dec 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    2
    Applicant Total
    9
    Review Days
    121

    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
    Resolve 2.0
    K Number
    K152322
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3260
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denali Corporation
    Date Received
    August 17, 2015
    Decision Date
    December 16, 2015
    Product Code
    PME
    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
    PME External Cleaning Solution

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PME), ordered by most recent decision date.

    KATANA Cleaner, KATANA Cleaner (Trial)

    FDA 510(k)
    FDA Class 2 ·Dental

    CeraClean

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Denali Corporation

    K Number Device Name
    K153191 Calcium Bridge
    K151945 Triumph Resin Dam
    K141503 DENALI 501CEMENT
    K132393 CERCOM II CEMENT
    K073101 AURAVENEER CEMENT
    K071158 AURALAY PIT & FISSURE SEALANT
    K070702 FUSION RESIN CEMENT AND CORE KIT
    K070693 AURAVUE PIT & FISSURE SEALANT