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

    ENDOFORM DENTAL TEMPLATE

    K Number: K101546 · Decision Jun 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    2
    Review Days
    20

    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
    ENDOFORM DENTAL TEMPLATE
    K Number
    K101546
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mesynthes, Ltd.
    Date Received
    June 3, 2010
    Decision Date
    June 23, 2010
    Product Code
    KGN
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KGN Wound Dressing With Animal-Derived Material(S)

    Similar 510(k) Clearances

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

    ECMT-100 WMD

    FDA 510(k)
    FDA Unclassified ·Unknown

    Catalyze

    FDA 510(k)
    FDA Unclassified ·Unknown

    Roosin Collagen Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    Roosin Collagen Powder

    FDA 510(k)
    FDA Unclassified ·Unknown

    MatriDerm

    FDA 510(k)
    FDA Unclassified ·Unknown

    Derma-Gide

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Mesynthes, Ltd.

    K Number Device Name
    K092096 ENDOFORM DERMAL TEMPLATE