BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    SILMET LTD.

    Reg #: 8030067 · FEI: 4108 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    58
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    SILMET LTD.
    Registration Number
    8030067
    FEI Number
    4108
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12 HASADNA
    City
    OR YEHUDA Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K103190

    Owner / Operator

    Firm Name
    SILMET LTD.
    Operator Number
    8030067
    Address
    12A HASADNA, --
    City
    OR YEHUDA
    State
    IL-NOTA
    Postal Code
    6022011
    Country
    IL
    Correspondent
    MOSHE - ZALSMAN

    US Agent

    Business Name
    Cargus International Inc.
    Contact Name
    Gavin Gabai
    Address
    135 N Route 9w
    City
    Congers
    State
    NY
    ZIP
    10920
    Country
    US
    Email
    [email protected]
    Phone
    845 2672600

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF
    Capsule, Dental, Amalgam DZS
    Alloy, Amalgam EJJ
    Zinc Oxide Eugenol EMB
    Agent, Tooth Bonding, Resin KLE
    Cement, Dental EMA

    Proprietary Names

    Universal Composite Hybrid Flowable ProFil ProFil Temp ProFil Flow LV ProFil Bulk ProFil Flow ProVeneer Flow ProFil Mono ProVeneer ProFil Seal ProFil Posterior Profil Universal ProFil Core ProFil Flow SE NOGAMA SPHERODON + PROCOPPER SPHERODON M DEXITER SPHERICAL AMALGAM DEXITER DISPERSED AMALGAM PROSILVER Alloy regular Spherodon M Econom Ventura High Alloy Amalgam dental alloy Avalloy Nualloy Ventura NG ProZoe ProLink Universal ProLink Cem Plus 8G Universal Adhesive ProLink 37% Etching Gel ProLink Cem Primer ProLink Ethanol ProLink Block ProLink Cem ProVeneer Bond ProLink M ProLink SE ProEtch GIC Luting Resin cement ProGlass Nine SA Resin Cement ProGlass Plus Cem ProGlass Two ProGlass Two LC GIC Filling ProBase RMGI Cement ProGlass Silver ProGlass One ProGlass Plus ProBase F Luting cem

    Establishment Types

    Manufacture Medical Device