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

    DynaMatrix/Dynamatrix Plus

    K Number: K161762 · Decision Jan 13, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    56
    Applicant Total
    16
    Review Days
    200

    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
    DynaMatrix/Dynamatrix Plus
    K Number
    K161762
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Biotech Incorporated
    Date Received
    June 27, 2016
    Decision Date
    January 13, 2017
    Product Code
    NPL
    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
    NPL Barrier, Animal Source, Intraoral

    Similar 510(k) Clearances

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

    Jason membrane

    FDA 510(k)
    FDA Class 2 ·Dental

    Augmented Gingival Matrix

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack

    FDA 510(k)
    FDA Class 2 ·Dental

    SwissMembrane X; SwissMembrane X Socket

    FDA 510(k)
    FDA Class 2 ·Dental

    Soft Tissue Augmentation Resorbable Matrix

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

    Other Clearances by Cook Biotech Incorporated

    K Number Device Name
    K232646 Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
    K201000 Biodesign Staple Line Reinforcement
    K191696 Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
    K171817 Biodesign Diaphragmatic Hernia Graft
    K162934 Biodesign Parastomal Hernia Repair Graft
    K170016 Biodesign Fistula Plug
    K170945 Biodesign Staple Line Reinforcement
    K162741 AxoGuard Nerve Connector
    K160136 Flowable Wound Matrix
    K161221 Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
    Search all 16 clearances from Cook Biotech Incorporated →