Manufacturer registered with FDA
Jining Orodeka Medical Equipment Co Ltd
JiNing, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 922 registrations outside the US
- Establishments
- 1China
Registered in 9 markets
Where regulators' registries name Jining Orodeka Medical Equipment 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 | Jining Orodeka Medical Equipment Co Ltd | 5 device types | — | Below |
| Serbia | ALIMS | Manufacturer | Jining Orodeka Medical Equipment Co., Ltd. | 7 | 2025–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Jining Orodeka Medical Equipment CO; LTD | 6 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Jining Orodeka Medical Equipment Co., Ltd. | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Jining Orodeka Medical Equipment Co Ltd | 1 | 2024–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | JINING ORODEKA MEDICAL EQUIPMENT CO., LTD | 1 | 2026–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | JINING ORODEKA MEDICAL EQUIPMENT CO., LTD | 1 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Jining Orodeka Medical Equipment Co. , Ltd. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Jining Orodeka Medical Equipment Co., Ltd. | 1 | 2020–2020 | 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 Jining Orodeka Medical Equipment 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 |
|---|---|---|---|---|
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Endodontic Measuring Probe | 2026 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Diamond Burs, Carbide Burs | 2026 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | gutta percha points | 2025 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | paper point | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Dental root canal instruments | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| JINING ORODEKA MEDICAL EQUIPMENT CO.,LTDFDA reg. 3017941947 | JiNing Shandong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10079261). 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.