BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    One Coat 7

    Reg #: 9613375 · FEI: 3002806620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COLTENE/WHALEDENT AG
    Registration Number
    9613375
    FEI Number
    3002806620
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FELDWIESENSTRASSE 20
    City
    ALTSTAETTEN Sankt Gallen
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K033760

    Owner / Operator

    Firm Name
    Coltene/Whaledent AG
    Operator Number
    9089944
    Address
    Altstaetten, Feldwiesenstrasse 20
    City
    Altstaetten
    State
    Sankt Gallen
    Postal Code
    CH 9450
    Country
    CH

    US Agent

    Business Name
    Coltene/Whaledent Inc
    Contact Name
    Tricia Cregger
    Address
    235 Ascot Parkway
    City
    Cuyahoga Falls
    State
    OH
    ZIP
    44223
    Country
    US
    Email
    [email protected]
    Phone
    330 9168904

    Products

    Device Name Product Code
    Agent, Tooth Bonding, Resin KLE

    Proprietary Names

    One Coat 7 One Coat Self-Etching Bond

    Establishment Types

    Manufacture Medical Device