Data / Medical devices / Canada / Novocol Pharmaceutical Of Canada, Inc.
Novocol Pharmaceutical Of Canada, Inc.: FDA-registered device maker in Cambridge Ontario, Canada, 1 510(k) clearance
Novocol Pharmaceutical Of Canada, Inc. is registered with the FDA (registration 3002807757) in Cambridge Ontario, Canada. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 27, 2014. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3002807757
- Address
- 25 Wolseley Court, Cambridge Ontario, Canada, N1R 6X3
- Owner or operator
- Novocol Pharmaceutical of Canada, Inc. (10048017)
- Roles
- Exporter to the US, Foreign private label distributor
- First device listed
- November 25, 2014
- Registered through
- 2026
- Brand names listed
- Benco, Biodentine, Darby, Evolution, Henry Schein, Patterson, Quala, Safco and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Dental | EMA | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Exporter to the US, Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| June 27, 2014 | K140132 | BIODENTINE | KIF | Substantially Equivalent | Septodont | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Dental
- All makers of Instrument, Filling, Plastic, Dental
- All makers of Resin, Root Canal Filling
- All makers of Cement, Dental
Updated June 27, 2014. 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.