Manufacturer registered with FDA
Smarter Alloys Inc
Cambridge, Canada. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 26 registrations outside the US
- Establishments
- 1Canada
Registered in 2 markets
Where regulators' registries name Smarter Alloys 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 | Manufacturer | Smarter Alloys Inc | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | SMARTER ALLOYS | 6 | 2017–2020 | 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 Smarter Alloys 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 |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | SmartArch | 2015 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Paradigm | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Smarter AlloysFDA reg. 3009655316 | Cambridge Ontario, Canada | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048942). 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.