Data / Medical devices / Canada / Scican Ltd.
Scican Ltd.: FDA-registered device maker in TORONTO Ontario, Canada, 6 510(k) clearances
Scican Ltd. is registered with the FDA (registration 8043629) in TORONTO Ontario, Canada. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 1, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 8043629
- FEI number
- 1000273801
- Address
- 1440 Don Mills RD., TORONTO Ontario, Canada, M3B 3P9
- Owner or operator
- Coltene/Whaledent AG (9089944)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- March 1, 1996
- Registered through
- 2026
- Brand names listed
- BRAVO G4, BioSonic UC30, BioSonic UC31, BioSonic UC32, Biosonic® Ultrasonic Cleaners, Data Logger Bravo (G), Data Logger Bravo (T), Data Logger Statim/Hydrim and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Block, Heating | JRG | 1 | Specification developer | accessdata.fda.gov |
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Manufacturer | accessdata.fda.gov |
| Device, Pasteurization, Hot Water | LDS | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Disinfector, Medical Devices | MEC | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2021 | K210326 | Bravo G4 Chamber Autoclave | FLE | Substantially Equivalent | Scican , Ltd. | accessdata.fda.gov |
| June 19, 2020 | K192910 | STATClave G4 Chamber Autoclave | FLE | Substantially Equivalent | Scican , Ltd. | accessdata.fda.gov |
| July 26, 2019 | K190062 | STATCLAVE G4 Chamber Autoclave | FLE | Substantially Equivalent | Scican , Ltd. | accessdata.fda.gov |
| July 10, 2012 | K112872 | STATIM 2000 G4 CASSETTE | FLE | Substantially Equivalent | Scican , Ltd. | accessdata.fda.gov |
| October 19, 2006 | K062418 | K-SPRAY, MODEL 085-2715 | EFB | Substantially Equivalent | Scican | accessdata.fda.gov |
| January 4, 1999 | K983679 | STATIM 5000 CASSETTE AUTOCLAVE | FLE | Substantially Equivalent | Scican | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 22, 2023 | 92682 | Class II | Ongoing | STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103 | The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE G4 has not been designed to sterilize liquid | accessdata.fda.gov |
Compare with other makers
- All makers of Cleaner, Ultrasonic, Medical Instrument
- All makers of Disinfector, Medical Devices
- All makers of Device, Pasteurization, Hot Water
- All makers of Sterilizer, Steam
- All makers of Handpiece, Air-Powered, Dental
- All makers of Block, Heating
Updated August 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.