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

    TOKUYAMA SOFRELINER

    K Number: K982537 · Decision Aug 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    22
    Review Days
    34

    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
    TOKUYAMA SOFRELINER
    K Number
    K982537
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tokuyama America, Inc.
    Date Received
    July 21, 1998
    Decision Date
    August 24, 1998
    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 Tokuyama America, Inc.

    K Number Device Name
    K022641 TOKUYAMA REBASE II
    K011854 TOKUYAMA M-BOND
    K011685 BISTITE II DC
    K010267 PALFIQUE ESTELITE LV CLEAR
    K002863 PALFIQUE ESTELITE LV
    K993917 TOKUYAMA ONE-UP-BOND F
    K991711 BISTITE II SC
    K980054 PALFIQUE ESTELITE
    K980058 TOKUSO MAC BOND II
    K980051 PALFIQUE ESTELITE PASTE
    Search all 22 clearances from Tokuyama America, Inc. →