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

    GEISTLICH COMBI-KIT COLLEGEN

    K Number: K112572 · Decision Dec 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    39
    Applicant Total
    27
    Review Days
    113

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    Basic Information

    Device Name
    GEISTLICH COMBI-KIT COLLEGEN
    K Number
    K112572
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geistlich Pharma AG
    Date Received
    September 6, 2011
    Decision Date
    December 28, 2011
    Product Code
    NPM
    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
    NPM Bone Grafting Material, Animal Source

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    Other Clearances by Geistlich Pharma AG

    K Number Device Name
    K260364 Device 300419 Strip
    K260532 Derma-Gide
    K251323 Device 104 Particulate
    K252253 Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
    K251062 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
    K251556 Device 300423 Granules
    K251786 Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®
    K251613 SwissGraft X
    K250833 SwissMembrane X; SwissMembrane X Socket
    K242510 Geistlich Bio-Flow®
    Search all 27 clearances from Geistlich Pharma AG →