Manufacturer registered with FDA
MEDPARK.Co., Ltd.
Busan, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 22023–2026
- Markets registered in
- 874 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name MEDPARK.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 | MEDPARK.Co., Ltd. | 2 clearances | 2023–2026 | Below |
| European Union | EUDAMED | Manufacturer | MedPark Co., Ltd. | 58 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MedPark co., Ltd.MedPark Co., Ltd. | 5 | 2020–2022 | Pure Global AI |
| Egypt | EDA | Manufacturer | MedPark co.,Ltd.,MedPark Co., Ltd., | 4 | 2023–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Medpark Co., Ltd. | 3 | 2024–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | MedPark Co Ltd | 2 | 2026–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | MedPark Co., Ltd | 1 | 2026–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MEDPARK 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 MEDPARK.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 |
|---|---|---|---|---|
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | Endobon® Bovine Xenograft MoldableEndobon® Bovine Xenograft Particulate | 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 MEDPARK.Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Jun 2026 | K253723 | BOSS | NPM Animal Source Bone Grafting Material |
| 13 Oct 2023 | K231672 | S1 | NPM Animal Source Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: IDOC Dental Lab (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDPARK CO., LTD.FDA reg. 3029731364 | Busan, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088661). 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.