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

    KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE

    K Number: K090919 · Decision Oct 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    56
    Applicant Total
    19
    Review Days
    184

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    Basic Information

    Device Name
    KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE
    K Number
    K090919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kensey Nash Corp.
    Date Received
    April 1, 2009
    Decision Date
    October 2, 2009
    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

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    Other Clearances by Kensey Nash Corp.

    K Number Device Name
    K103787 MEDEOR MATRIX
    K091192 KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX
    K091499 MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)
    K073519 QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
    K071695 KENSEY NASH MACROPORE SHIELD
    K072384 MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
    K072195 THROMCAT THROMBECTOMY CATHETER SYSTEM
    K071237 COPIOS BONE VOID FILLER SPONGE AND PASTE
    K062870 TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03
    K061772 TRIACTIV FX EMBOLIC PROTECTION SYSTEM
    Search all 19 clearances from Kensey Nash Corp. →