Manufacturer registered with FDA
OSTEONIC Co., Ltd.
Seoul, South Korea. Lists 4 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 44
- 510(k) clearances
- 32015–2021
- Markets registered in
- 12235 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name OSTEONIC 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 | OSTEONIC Co., Ltd. | 3 clearances | 2015–2021 | Below |
| European Union | EUDAMED | Manufacturer | OSTEONIC Co., Ltd. | 106 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | OSTEONIC CO., LTD.OSTEONIC CO LTD | 36 | 2015–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Osteonic Co Ltd | 25 | 2021–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | OSTEONIC CO., LTDOSTEONIC CO., LTD. · OSTEONIC CO.,LTD · +2 | 17 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Osteonic Co., Ltd | 14 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OSTEONIC CO., LTD.OSTEONIC Co., Ltd. | 12 | 2016–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | OSTEONIC Co., LtdOSTEONIC Co., Ltda. · OSTEONIC Co., Ltd. | 10 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | OSTEONIC Co. Ltd.OSTEONIC Co. LTD | 8 | 2024–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | OSTEONIC Co., Ltd | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | OSTEONIC Co., LtdOSTEONIC Co., Ltd. | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 奥思泰医疗器械有限公司OSTEONIC Co., Ltd. | 1 | — | 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 OSTEONIC 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 |
|---|---|---|---|---|
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | OPTIMUS CMF System | 2015 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | OPTIMUS CMF System | 2015 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | POWER SYSTEMT4A.10010T4A.10010FT4A.10020T4A.10020FT4A.10030T4A.10030FT4A.10040T4A.10050T4A.10060 31 moreT4A.10070T4A.12010T4A.12010FT4A.12020T4A.12020FT4A.12030T4A.12030FT4A.12040T4A.12050T4A7010T4A7010FT4A7020T4A7020FT4A7030T4A7030FT4A7040T4A7050T4A8010T4A8010FT4A8020T4A8020FT4A8030T4A8030FT4A8040T4A8050T4A8060T4A8070T4B.10010T4B.12010T4B7010Y2C.15020 | 2022 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | ORTHO MI SYSTEM | 2021 |
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 |
|---|---|---|
| OSTEONIC CO., LTD.FDA reg. 3011530718 | Seoul, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048673). 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.