Registered with FDA
Novocol Pharmaceutical of Canada, Inc.
Cambridge, Canada. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Canada
Registered in 2 markets
Where regulators' registries name Novocol Pharmaceutical of Canada, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Novocol Pharmaceutical of Canada, Inc. | 4 device types | — | Below |
| Taiwan | TFDA | Manufacturer | NOVOCOL PHARMACEUTICAL OF CANADA INC. | 1 | 2013–2013 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Novocol Pharmaceutical of Canada, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | BencoDarbyEvolutionHenry ScheinPattersonQualaSafcoSafety Plus XLSeptoject DisposableXL Septoject | 2015 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | Ultra Safety Handle | 2014 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Biodentine | 2015 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | Biodentine | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Novocol Pharmaceutical of Canada, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Septodont (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NOVOCOL PHARMACEUTICAL OF CANADA, INC.FDA reg. 3002807757 | Cambridge Ontario, Canada | Foreign exporter, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048017). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.