Data / Medical devices / Canada / Henry Schein Canada, Inc.
Henry Schein Canada, Inc.: FDA-registered device maker in Niagara-on-the-Lake Ontario, Canada, 3 510(k) clearances
Henry Schein Canada, Inc. is registered with the FDA (registration 3006665149) in Niagara-on-the-Lake Ontario, Canada. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 8, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006665149
- Address
- 345 Townline Road, Niagara-on-the-Lake Ontario, Canada, L0S 1J0
- Owner or operator
- Henry Schein Canada, Inc. (10055364)
- Roles
- Exporter to the US
- First device listed
- July 13, 2017
- Registered through
- 2026
- Brand names listed
- DB + POS EACH, DB+ 20 ANT FULL SET, DB+ 20 POS FULL SET, DB+ ANT EACH, Henry Schein Earloop Procedure Masks, Solocem
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Dental | EMA | 2 | Exporter to the US | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Exporter to the US | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| January 8, 2013 | K121621 | SOLOCEM | EMA | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| September 20, 2005 | K051291 | NON-STERILE SURGICAL MASK | FXX | Substantially Equivalent | A.R. Medicom, Inc. | accessdata.fda.gov |
| November 4, 1992 | K924526 | DENTURE PLASTIC TEETH | ELM | Substantially Equivalent | Austenal, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 8, 2013. 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.