Registered with FDA
Toyo Polymack Co., Ltd.
Taito-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
- 24 registrations outside the US
- Establishments
- 1Japan
Registered in 2 markets
Where regulators' registries name Toyo Polymack Co., Ltd. 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 | Toyo Polymack Co., Ltd. | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | TOYO POLYMACK CO., LTD.TOYO POLYMACK CO.,LTD · TOYO POLYMACK CO.,LTD. · +1 | 4 | 2012–2021 | 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 Toyo Polymack Co., Ltd. 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 Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | — | 2011 |
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 |
|---|---|---|
| TOYO POLYMACK CO., LTD.FDA reg. 3003627846 | Taito-Ku Tokyo, Japan | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10039084). 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.