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

    GDC-3200 DENTAL SOLDER

    K Number: K910065 · Decision Mar 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    626
    Applicant Total
    46
    Review Days
    65

    Basic Information

    Device Name
    GDC-3200 DENTAL SOLDER
    K Number
    K910065
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    DERINGER-NEY INC.
    Date Received
    January 9, 1991
    Decision Date
    March 15, 1991
    Product Code
    EJT
    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
    EJT Alloy, Gold-Based Noble Metal

    Similar 510(k) Clearances

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

    PROMETAL HN86

    FDA 510(k)
    FDA Class 2 ·Dental

    BIO 60

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTA REFLEX

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTA SOLDER 1090 W

    FDA 510(k)
    FDA Class 2 ·Dental

    NDX-40 ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM

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

    Other Clearances by DERINGER-NEY INC.

    K Number Device Name
    K933178 GDC 3509
    K930482 DENTAL CASTING ALLOY, MODIFICATION - PF-3
    K930481 DENTAL CASTING ALLOY MODIFICATION-PF-4
    K925273 GDC 3445
    K920922 GDC 3367
    K920060 DENTAL SOLDER ALLOY
    K920887 GDC-3338, DENTAL SOLDER ALLOY
    K904695 GDC-1501
    K904614 GDC-1475
    K901532 GDC 3084 CASTING ALLOY
    Search all 46 clearances from DERINGER-NEY INC. →