Manufacturer registered with FDA
North Eos Industries Inc
TAICHUNG CITY, Taiwan. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 530 registrations outside the US
- Establishments
- 1Taiwan
Registered in 5 markets
Where regulators' registries name North Eos Industries 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 | North Eos Industries Inc | 3 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | NORTH EOS INDUSTRIES, INC. | 19 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | NORTH EOS INDUSTRIES,INC. | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | North Eos Industries Inc | 4 | 2018–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | NORTH EOS INDUSTRIES, INC. | 1 | 2007–2007 | 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 North Eos Industries 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 |
|---|---|---|---|---|
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | DentBoxEOS BRAND | 2001 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | EOS BEAUTY TRAY | 2006 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | DentSpec | 2018 |
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 |
|---|---|---|
| NORTH EOS INDUSTRIES, INC.FDA reg. 8043235 | TAICHUNG CITY, Taiwan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8043235). 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.