Manufacturer registered with FDA
Yancheng Denrum Medical Apparatus Co Ltd
Yancheng, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 670 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Yancheng Denrum Medical Apparatus 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 | Yancheng Denrum Medical Apparatus Co Ltd | 4 device types | — | Below |
| Colombia | INVIMA | Manufacturer | YANCHENG DENRUM MEDICAL APPARATUS CO., LTD.YANCHENG DENRUM MEDICAL APPARATUS CO., LTD | 58 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Yancheng Denrum Medical Apparatus Co.,LtdYanCheng Denrum Medical Apparatus Co.,Ltd. · YanCheng Denrum Medical Apparatus Co.,Ltd | 8 | 2009–2017 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | YANCHENG DENRUM MEDICAL APPARATUS CO. LTD. | 2 | 2017–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Yancheng Denrum Medical Apparatus Co Ltd | 1 | 2017–2017 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | YANCHENG DENRUM MEDICAL APPARATUS CO., LTD | 1 | 2019–2019 | 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 Yancheng Denrum Medical Apparatus 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 |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Archwire | 2015 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Elastomer | 2014 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Bands | 2014 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic Brackets | 2014 |
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 |
|---|---|---|
| YANCHENG DENRUM MEDICAL APPARATUS CO.,LTD.FDA reg. 3006155566 | Yancheng Jiangsu, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046975). 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.