BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Coltolux Comfort LED Curing Light

    Reg #: 2416455 · FEI: 2416455 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COLTENE/WHALEDENT INC.
    Registration Number
    2416455
    FEI Number
    2416455
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    235 Ascot Pkwy
    City
    CUYAHOGA FALLS
    State
    OH
    ZIP
    44223
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223142

    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

    Products

    Device Name Product Code
    Activator, Ultraviolet, For Polymerization EBZ

    Proprietary Names

    Coltolux Comfort LED Curing Light

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)