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

    SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT

    K Number: K982305 · Decision Sep 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    9
    Review Days
    83

    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
    SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT
    K Number
    K982305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sulzer Calcitek, Inc.
    Date Received
    July 1, 1998
    Decision Date
    September 22, 1998
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

    Similar 510(k) Clearances

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

    MegaGen Zygoma Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    INOSS System

    FDA 510(k)
    FDA Class 2 ·Dental

    Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

    FDA 510(k)
    FDA Class 2 ·Dental

    Adin Long Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    ZENEX Implant System_Short (R-System)

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

    Other Clearances by Sulzer Calcitek, Inc.

    K Number Device Name
    K010073 SPLINE DENTAL IMPLANT SYSTEM
    K001786 TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
    K984536 REMOVABLE CUFF ABUTMENT
    K981562 SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT
    K973521 VARIABLE PARALLEL PIN
    K970752 SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
    K970127 EDOSSEOUS DENTAL IMPLANT
    K964768 THREADLOC DENTAL IMPLANT SYSTEMS