BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Zipbond

    K Number: K191656 · Decision Dec 2, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    418
    Applicant Total
    6
    Review Days
    164

    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
    Zipbond
    K Number
    K191656
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sdi Limited
    Date Received
    June 21, 2019
    Decision Date
    December 2, 2019
    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 Sdi Limited

    K Number Device Name
    K222581 Stela Automix System
    K222583 Stela Capsule System
    K214118 Riva Cem Automix
    K172047 Riva Star
    K102984 AURA