BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC

    K Number: K983161 · Decision Sep 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    21

    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
    KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC
    K Number
    K983161
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3810
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sabre-K , Ltd.
    Date Received
    September 9, 1998
    Decision Date
    September 30, 1998
    Product Code
    ELR
    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
    ELR Post, Root Canal

    Similar 510(k) Clearances

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

    FIBER-METAL POST

    FDA 510(k)
    FDA Class 1 ·Dental

    FRC POSTEC PLUS

    FDA 510(k)
    FDA Class 1 ·Dental

    EVERSTICK POST

    FDA 510(k)
    FDA Class 1 ·Dental

    FIBIOCORE

    FDA 510(k)
    FDA Class 1 ·Dental

    CARBON POST

    FDA 510(k)
    FDA Class 1 ·Dental

    FRC POSTEC

    FDA 510(k)
    FDA Class 1 ·Dental
    View all