Manufacturer registered with FDA
Forest-One Co., Ltd.
Funabashi, Japan. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1Japan
Registered in 3 markets
Where regulators' registries name Forest-One 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 | Manufacturer | Forest-One Co., Ltd. | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | FOREST-ONE CO.,LTD. | 2 | 2023–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Forest-One Co., Ltd. | 1 | 2024–2024 | 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 Forest-One 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 |
|---|---|---|---|---|
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | T1 InitialT1-LHT1-LST1-MHT1-MST1-SHT1-SST2-MHT3 InitialT3-LH 5 moreT3-LST3-MHT3-MST3-SHT3-SS | 2023 |
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 |
|---|---|---|
| FOREST-ONE CO.,LTD.FDA reg. 3021741991 | Funabashi Chiba, Japan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087238). 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.