Not currently registered with FDA under this name
Biocetec Co., Ltd.
Seoul, South Korea. Named as applicant on 4 dental 510(k) clearances between 2017 and 2023. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42017–2023
- Markets registered in
- 78 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Biocetec 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 | Applicant | Biocetec Co., Ltd. | 4 clearances | 2017–2023 | Below |
| Taiwan | TFDA | Manufacturer | Biocetec Co., Ltd. | 3 | 2020–2023 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BIOCETEC CO., LTD. | 1 | 2024–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BIOCETEC CO. LTD | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Biocetec Co., Ltd. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BIOCETEC CO., LTD. | 1 | 2022–2022 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | BIOCETEC 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
510(k) clearances
Clearances on which FDA names Biocetec Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Jun 2023 | K231635 | A-Line Advanced | NJM Orthodontic Ceramic Bracket |
| 17 Jan 2020 | K190871 | Bio-TackS Orthodontic Mini Implant | OAT Orthodontic Endosseous Implant |
| 22 Jan 2019 | K182193 | S-Line | NJM Orthodontic Ceramic Bracket |
| 14 Jun 2017 | K163467 | C-Line Orthodontic Ceramic Bracket | NJM Orthodontic Ceramic Bracket |
Sources
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 of the most recent filing, which can be a US agent.