Manufacturer registered with FDA
United Dental Changzhou
Changzhou, China. Lists 11 dental device types with FDA across 1 registered establishment.
- Device types listed
- 11
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 510 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name United Dental Changzhou 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 | United Dental Changzhou | 11 device types | — | Below |
| Peru | DIGEMID | Manufacturer | UNITED DENTAL CHANGZHOU | 4 | 2024–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | UNITED DENTAL CHANGZHOU | 3 | 2022–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | United Dental Changzhou | 2 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | UNITED DENTAL CHANGZHOU | 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
Devices listed with FDA
What United Dental Changzhou 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 Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Orthodontic Expansion Screws | 2020 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Rotary files/Root canal files, Hand use files/Manual files, Sterile Root Canal Files | 2019 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Stainless steel Wires, Orthodontic Niti Wires | 2019 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Crimple hooks, Crimple hooks | 2019 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Irrigation needles | 2019 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Irrigation needles | 2020 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic metal Brackets, Orthodontic metal self ligating Brackets | 2019 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta percha points | 2019 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Paper points | 2019 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Plugger | 2019 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Rotary files/Root canal files, Hand use files/Manual files, Sterile Endodontic Hand 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 |
|---|---|---|
| UNITED DENTAL CHANGZHOUFDA reg. 3015526995 | Changzhou Jiangsu, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062136). 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.