SCICAN LTD.

FDA Device Registration & Listing · TORONTO Ontario, CA · Registration 8043629

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8043629
FEI Number
1000273801
Entity Name
SCICAN LTD.
City/State/Country
TORONTO Ontario, CA
Establishment Address
1440 DON MILLS RD., TORONTO Ontario M3B 3P9, CA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Coltene/Whaledent AG (Owner Number: 9089944)
Owner / Operator Contact Address
Altstaetten, Feldwiesenstrasse 20, Altstaetten, CH-SG CH 9450, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2019-08-09
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2021-09-16
JRG Block, Heating Clinical Chemistry Class 1 862.2050 2018-12-13
MEC Disinfector, Medical Devices General Hospital Class 2 880.6992 2018-12-13
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2018-12-13
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 1996-03-01
LDS Device, Pasteurization, Hot Water General Hospital Class 2 880.6991 2018-12-13
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2018-12-13
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2020-11-05
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2018-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

Tricia Cregger Business: Coltene/Whaledent Inc Email: tricia.cregger@coltene.com Phone: (330) 9168904

Related Public Records

Same Entity

Coltene/Whaledent AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012832388 DIATECH DENTAL INC Mount Pleasant, SC, US
8030962 Micro-Mega SA BESANCON Doubs, FR
2416455 COLTENE/WHALEDENT INC. CUYAHOGA FALLS, OH, US
9613375 COLTENE/WHALEDENT AG ALTSTAETTEN Sankt Gallen, CH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K021223 Sauter AG BELIMED STEAM STERILIZER, MODEL TOP 5000 2002-06-26
K050263 M.O. Com S.R.L. MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU 2006-11-21
K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece 2022-11-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0016-2026 Getinge Disinfection Ab Ljungadalsgatan 2
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Z-0018-2014 Getinge Disinfection Ljungadalsgatan 2
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Z-0008-2025 Young Dental Manufacturing I, LLC 1
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Z-0036-2011 Cenorin 2
HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 520***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended to use at healthcare provide clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean and high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.
Z-0037-2011 Cenorin 2
HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). This device does not have the external heater unit known as High Throughput Heater. Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 540***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended for use at healthcare provided clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043629. Last updated year: 2026. Please use registration number 8043629 when referencing this establishment in official correspondence.
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