BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092

    K Number: K051050 · Decision Jun 29, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    418
    Applicant Total
    5
    Review Days
    65

    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
    SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092
    K Number
    K051050
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Schutz-Dental GmbH
    Date Received
    April 25, 2005
    Decision Date
    June 29, 2005
    Product Code
    KLE
    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
    KLE Agent, Tooth Bonding, Resin

    Similar 510(k) Clearances

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

    Any-Etch

    FDA 510(k)
    FDA Class 2 ·Dental

    Porcelain Etch Gel

    FDA 510(k)
    FDA Class 2 ·Dental

    Adhese 2

    FDA 510(k)
    FDA Class 2 ·Dental

    Bond-PR™ Universal Adhesive

    FDA 510(k)
    FDA Class 2 ·Dental

    VITA VMLC Primer

    FDA 510(k)
    FDA Class 2 ·Dental

    els unibond

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

    Other Clearances by Schutz-Dental GmbH

    K Number Device Name
    K133268 TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS
    K071010 TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS
    K052073 FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
    K052189 REVENEER CERAMIC REPAIR SYSTEM