Manufacturer registered with FDA
TOSOH Corporation
Minato-ku, Japan. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 131,711 registrations outside the US
- Establishments
- 1Japan
Registered in 13 markets
Where regulators' registries name TOSOH Corporation 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 | TOSOH Corporation | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Tosoh Corporation | 392 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Tosoh Corporation | 309 | 2021–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Tosoh Corporation | 295 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | TOSOH CORPORATION | 223 | 1999–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Tosoh Corporation | 173 | — | Pure Global AI |
| China | NMPA | Registration holder | 东曹株式会社Tosoh Corporation东曹株式会社 Tosoh Corporation | 149 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TOSOH CORPORATION | 112 | 2017–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | TOSOH CORPORATIONTOSOH CORP. | 33 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TOSOH CORPORATION | 11 | 2008–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | TOSOH Corporation | 7 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Tosoh Corporation | 5 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TOSOH CORPORATION | 2 | 2005–2005 | 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 TOSOH Corporation 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 Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | — | 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 |
|---|---|---|
| TOSOH CERAMICS CO., LTD.FDA reg. 3008787992 | TOYAMA-SHI, Japan | Contract manufacturer |
Other names on FDA records
Tosoh Ceramics Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056996). 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.