Manufacturer registered with FDA
CG Bio Co., Ltd.
Seoul, 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
- 15547 registrations outside the US
- Establishments
- 1South Korea
Registered in 15 markets
Where regulators' registries name CG Bio 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 | CG Bio Co., Ltd. | 1 device types | — | Below |
| Colombia | INVIMA | Registration holder | CG BIOCG BIO CO., LTD · CG BIO CO, LTD. · +2 | 506 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CG BIO CO. LTD.CG BIO CO., LTD. · CGBIO CO., LTD. | 6 | 2021–2026 | Pure Global AI |
| China | NMPA | Registration holder | 细基生物株式会社CG Bio Co., Ltd.细基生物株式会社CG Bio Co.,Ltd. · 细基生物株式会社CG Bio Co.,Ltd | 6 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CG BIO Co., Ltd.CGBIO Co., Ltd. | 6 | 2022–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CG Bio Co., Ltd.CG Bio Co.,Ltd. | 6 | 2018–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | CG Bio Co., Ltd.CG Bio Co., Ltd | 4 | 2019–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | CG Bio Co., Ltd. | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | CGBIO Co Ltd | 2 | 2019–2021 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | CG Bio CO.,Ltd.CG Bio Co, Ltd. | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | CG Bio CO., Ltd. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | CG Bio Co.,Ltd. | 1 | — | Pure Global AI |
| Philippines | FDA Philippines | Manufacturer | CGBio Co., Ltd. | 1 | 2025–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | CG Bio Co., Ltd. | 1 | 2026–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | (주)시지바이오(CG Bio., Ltd.) | 1 | 2012–2012 | 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 CG Bio 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 | Bongros | 2023 |
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
CG Bio 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: Bioalpha, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 May 2009 | K090793 | BONGROS HA | Bioalpha, Inc. | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CG BIO CO., LTD.FDA reg. 3017036472 | Hwaseong-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10040923). 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.