Manufacturer registered with FDA
Beijing Naton Technology Group Co. Ltd.
Beijing, China. Lists 5 dental device types with FDA across 1 registered establishment, and holds 10 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 13
- 510(k) clearances
- 102001–2025
- Markets registered in
- 151,017 registrations outside the US
- Establishments
- 1Finland
510(k) clearances per year, 2000–2026
Registered in 15 markets
Where regulators' registries name Beijing Naton Technology Group 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 | Beijing Naton Technology Group Co. Ltd. | 10 clearances | 2001–2025 | Below |
| European Union | EUDAMED | Manufacturer | Inion Oy | 802 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | INION OYInion Oy · INION Oy · +2 | 58 | 2003–2022 | Pure Global AI |
| Canada | Health Canada | Registration holder | INION OY | 42 | 2001–2005 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | INION OYInion Oy | 25 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Inion Oy | 22 | 2023–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | INION OYINION LTD. · Inion Oy | 21 | 2003–2024 | Pure Global AI |
| Colombia | INVIMA | Registration holder | INION LTD.INION OY | 14 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | INION OY | 11 | 2011–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Inion Oy | 9 | 2008–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Inion OY | 5 | 2008–2008 | Pure Global AI |
| Egypt | EDA | Manufacturer | Inion OY,inion Oy, | 3 | 2020–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Inion OyINION LTD. | 3 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | INION OY | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | INION OY | 1 | 2023–2023 | 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 Beijing Naton Technology Group 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 |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | Inion CPS 1.5/2/2.5 Bioabsorbable Fixation SystemInion CPS Baby 1.5 Bioabsorbable Fixation SystemInion CPS Baby Biodegradable Fixation SystemInion CPS Biodegradable Fixation SystemInion CPS InstrumentInion CPS Orbital PlatesInion Instrument | 2011 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Inion CPS 1.5/2/2.5 Bioabsorbable Fixation SystemInion CPS Baby 1.5 Bioabsorbable Fixation System | 2026 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Inion Instrumentation | 2011 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | Inion BioRestore Synthetic Bone Graft Substitute | 2011 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Maker | Inion GTR Accessory InstrumentInion GTR Biodegradable Membrane System | 2011 |
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 Beijing Naton Technology Group Co. Ltd. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Nov 2025 | K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | JEY Bone Plate |
| 29 Jan 2013 | K122890 | INION CPS ORBITAL PLATES | JEY Bone Plate |
| 24 Jul 2007 | K070784 | INION BIORESTORE | LYC Synthetic Bone Grafting Material |
| 20 Sep 2005 | K052444 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | JEY Bone Plate |
| 27 May 2005 | K051341 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 | JEY Bone Plate |
| 31 Mar 2004 | K033074 | INION GTR BIODEGRADABLE MEMBRANE SYSTEM | NPK Intraoral Synthetic Barrier |
| 30 Oct 2003 | K033194 | INION CPS BABY 1.5 BIOABSORBABLE SYSTEM | JEY Bone Plate |
| 5 Oct 2001 | K013039 | INION CPS 2.0 ORTHOGNATHIC PLATE | JEY Bone Plate |
| 15 Mar 2001 | K010351 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | JEY Bone Plate |
| 14 Mar 2001 | K010352 | CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INION OYFDA reg. 9710629 | TAMPERE Pirkanmaa, Finland | Manufacturer, Specification developer |
Other names on FDA records
Inion Oy
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035021). 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.