Registered with FDA
Henry Schein Canada, Inc.
Niagara-on-the-Lake, Canada. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 219 registrations outside the US
- Establishments
- 1Canada
Registered in 2 markets
Where regulators' registries name Henry Schein 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 | Henry Schein Canada, Inc. | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | HENRY SCHEIN CANADA INC. | 19 | 2003–2003 | 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 Henry Schein 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 |
|---|---|---|---|---|
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Lister | DB + POS EACHDB+ 20 ANT FULL SETDB+ 20 POS FULL SETDB+ ANT EACH | 2022 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Solocem | 2017 |
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
Henry Schein 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: Coltene/Whaledent AG (1), Austenal, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Jan 2013 | K121621 | SOLOCEM | Coltene/Whaledent AG | EMA Dental Cement |
| 4 Nov 1992 | K924526 | DENTURE PLASTIC TEETH | Austenal, Inc. | ELM Teeth Plastic Denture |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HENRY SCHEIN CANADA, INC.FDA reg. 3006665149 | Niagara-on-the-Lake Ontario, Canada | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10055364). 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.