BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ProLink Cem Primer

    Reg #: 8030067 · FEI: 4108 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SILMET LTD.
    Registration Number
    8030067
    FEI Number
    4108
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12 HASADNA
    City
    OR YEHUDA Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K110403

    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
    Agent, Tooth Bonding, Resin KLE

    Proprietary Names

    ProLink Cem Primer ProLink Ethanol ProLink Universal 37% Etching Gel ProLink Cem Plus ProLink Block ProEtch ProVeneer Bond ProLink SE 8G Universal Adhesive ProLink M ProLink Cem ProLink

    Establishment Types

    Manufacture Medical Device