Manufacturer registered with FDA
韩国速压科技有限公司SOYAGREENTEC Co.,Ltd.
Hwaseong-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 525 registrations outside the US
- Establishments
- 1South Korea
Registered in 5 markets
Where regulators' registries name 韩国速压科技有限公司SOYAGREENTEC 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 | 韩国速压科技有限公司SOYAGREENTEC Co.,Ltd. | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | SOYAGREENTEC CO., LTD | 10 | 2014–2015 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SOYAGREENTEC, CO., Ltd | 7 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SOYAGREENTEC CO., LTDASOYAGREENTEC CO., LTD | 6 | 2012–2022 | Pure Global AI |
| China | NMPA | Registration holder | 韩国速压科技有限公司SOYAGREENTEC Co.,Ltd.韩国速压科技有限公司Soyagreentec Co., Ltd. | 2 | — | 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 韩国速压科技有限公司SOYAGREENTEC 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 |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | OSTEON | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
韩国速压科技有限公司SOYAGREENTEC Co.,Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: GENOSS Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Apr 2007 | K062834 | OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 | GENOSS Co., Ltd. | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SOYAGREENTEC CO.,LTDFDA reg. 3004525100 | Hwaseong-si Gyeonggi, South Korea | Contract sterilizer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9062715). 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.