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

    VILA

    K Number: K951381 · Decision Apr 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    191
    Applicant Total
    8
    Review Days
    31

    Basic Information

    Device Name
    VILA
    K Number
    K951381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3750
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    HEALTH-DENT INTL., INC.
    Date Received
    March 27, 1995
    Decision Date
    April 27, 1995
    Product Code
    DYH
    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
    DYH Adhesive, Bracket And Tooth Conditioner, Resin

    Similar 510(k) Clearances

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

    Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive

    FDA 510(k)
    FDA Class 2 ·Dental

    BracePaste Fluoride Sealant

    FDA 510(k)
    FDA Class 2 ·Dental

    3M™ Transbond™ Orthodontic Adhesive

    FDA 510(k)
    FDA Class 2 ·Dental

    AlignerFlow LC

    FDA 510(k)
    FDA Class 2 ·Dental

    TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520

    FDA 510(k)
    FDA Class 2 ·Dental

    FiteBac CC OrthoSeal

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

    Other Clearances by HEALTH-DENT INTL., INC.

    K Number Device Name
    K972198 DENT-TEMP ACRYLIC
    K953405 HEMA-BENZ
    K951220 HEMA-GLU
    K951380 VILA PC
    K951235 GIROC
    K951236 PRO-LOCK
    K951237 ALGI-BAND