BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    SCICAN LTD.

    Reg #: 8043629 · FEI: 1000273801 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    29
    Establishment Types
    5
    Classifications
    7

    Registration Details

    Registration Name
    SCICAN LTD.
    Registration Number
    8043629
    FEI Number
    1000273801
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1440 DON MILLS RD.
    City
    TORONTO Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K190062

    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
    Sterilizer, Steam FLE
    Block, Heating JRG
    Disinfector, Medical Devices MEC
    Handpiece, Air-Powered, Dental EFB
    Cleaner, Ultrasonic, Medical Instrument FLG
    Device, Pasteurization, Hot Water LDS
    Medical Device Data System OUG

    Proprietary Names

    STATCLAVE BRAVO G4 ENSURE Incubator Hydrim C61WD Instrument Washer-Disinfector Hydrim C61WD Instrument Washer-Disinfector with Lumen Cleaning System HYDRIM C61WD G4 Instrument Washer-Disinfector K-Spray Handpiece Spray STATMATIC Spray STATCARE Handpiece Spray Biosonic® Ultrasonic Cleaners BioSonic UC32 BioSonic UC30 StatClean Dentronix MP-US Plus BioSonic UC31 HYDRIM C61W G4 INSTRUMENT WASHER HYDRIM L110W G4 INSTRUMENT WASHER HIP Ultra Cleaning Solution with Instrument Protection HIP Cleaning Solution with Instrument Protection HYDRIM L110W Instrument Washer HYDRIM 112W G4+ Instrument Washer HIP Cleaning Solution with Instrument Protection for HYDRIM 112 STATIM 5000 G4 STATIM 2000 G4 STATCLAVE G4 Chamber Autoclave STATIM 5000 Cassette Autoclave Data Logger Statim/Hydrim Data Logger Bravo (T) Data Logger Bravo (G)

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor