Manufacturer registered with FDA
PURGO BIOLOGICS Inc.
Seongnam-si, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 6
- 510(k) clearances
- 52018–2024
- Markets registered in
- 15242 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 15 markets
Where regulators' registries name PURGO BIOLOGICS Inc. 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 | PURGO BIOLOGICS Inc. | 5 clearances | 2018–2024 | Below |
| European Union | EUDAMED | Manufacturer | Purgo Biologics Inc. | 191 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | PURGO BIOLOGICS INC. | 8 | 2013–2023 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PURGO BIOLOGICS INC. | 7 | 2018–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Purgo Biologics Inc | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Purgo Biologics Inc. | 6 | 2015–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Purgo Biologics Inc | 4 | — | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | Purgo Biologics Inc. | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Purgo Biologics Inc | 3 | 2023–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | PURGO BIOLOGICS INC | 3 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Purgo Biologics Inc. | 3 | 2025–2025 | Pure Global AI |
| China | NMPA | Registration holder | 璞固生物科技有限公司 Purgo Biologics Inc.璞固生物科技有限公司Purgo Biologics Inc. | 2 | — | Pure Global AI |
| Japan | PMDA | Registration holder | Ｐｕｒｇｏ Ｂｉｏｌｏｇｉｃｓ Ｉｎｃ． | 2 | 2017–2017 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Purgo Biologics Inc. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PURGO BIOLOGICS INC | 1 | 2021–2021 | 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 PURGO BIOLOGICS Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | THE GraftTHE Graft Collagen | 2018 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Maker | CYTOSHIELDOpenTexTBS PTFE Membrane | 2023 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | THE Cover | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names PURGO BIOLOGICS Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Jul 2024 | K230305 | THE Graft Collagen | NPM Animal Source Bone Grafting Material |
| 6 Oct 2023 | K230091 | THE Cover | NPL Intraoral Animal Source Barrier |
| 11 May 2023 | K222549 | OpenTex | NPK Intraoral Synthetic Barrier |
| 14 Feb 2020 | K191737 | The Graft Bone Substitute | NPM Animal Source Bone Grafting Material |
| 20 Jul 2018 | K173188 | The Graft Natural Bone Substitute | NPM Animal Source Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PURGO BIOLOGICS INC.FDA reg. 3014448321 | Seongnam-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053793). 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.