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

    CARBON FIBER BRIDGE, MODEL 28757

    K Number: K031070 · Decision Jul 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    92
    Review Days
    90

    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
    CARBON FIBER BRIDGE, MODEL 28757
    K Number
    K031070
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nobel Biocare AB
    Date Received
    April 4, 2003
    Decision Date
    July 3, 2003
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

    Similar 510(k) Clearances

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

    DB 4000 High Impact Denture Base

    FDA 510(k)
    FDA Class 2 ·Dental

    Denture Base

    FDA 510(k)
    FDA Class 2 ·Dental

    LuxCreo Flexible Partial Denture Resin

    FDA 510(k)
    FDA Class 2 ·Dental

    TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)

    FDA 510(k)
    FDA Class 2 ·Dental

    UltraPrint-Dental Denture UV

    FDA 510(k)
    FDA Class 2 ·Dental

    Freeprint® denture flex

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

    Other Clearances by Nobel Biocare AB

    K Number Device Name
    K252197 Nobel Biocare S Series Implants
    K243834 NobelZygoma TiUltra Implant system
    K240346 NobelProcera Zirconia Implant Bridge
    K233208 NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
    K231898 DTX Studio Clinic (4.0)
    K223677 Titanium Abutment Blank Nobel Biocare N1 TCC
    K221921 DTX Studio Clinic 3.0
    K213562 DTX Studio Clinic 3.0
    K202452 NobelProcera Zirconia Implant Bridge
    K203156 DTX Studio Clinic
    Search all 92 clearances from Nobel Biocare AB →