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

    CERA E DENTAL ALLOY

    K Number: K980661 · Decision May 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    193
    Applicant Total
    7
    Review Days
    70

    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
    CERA E DENTAL ALLOY
    K Number
    K980661
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    European Dental Imports, Inc.
    Date Received
    February 20, 1998
    Decision Date
    May 1, 1998
    Product Code
    EJS
    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
    EJS Alloy, Other Noble Metal

    Similar 510(k) Clearances

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

    BRIGHT GOLD XH

    FDA 510(k)
    FDA Class 2 ·Dental

    SIMIDUR SUPERIOR

    FDA 510(k)
    FDA Class 2 ·Dental

    STERNGOLD 1, MODEL 1127781

    FDA 510(k)
    FDA Class 2 ·Dental

    ECO E4

    FDA 510(k)
    FDA Class 2 ·Dental

    STERNGOLD 66, MODEL #1180230

    FDA 510(k)
    FDA Class 2 ·Dental

    SIMIDUR S1S

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

    Other Clearances by European Dental Imports, Inc.

    K Number Device Name
    K982129 ANTAGON PORCELAIN
    K981001 ORION VESTA DENTAL ALLOY
    K981002 ORION WX DENTAL ALLOY
    K981000 CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN
    K980660 BIOGOLD PLUS DENTAL ALLOY
    K980597 CARRARA PDF, CARRARA H, CARRARA R