Manufacturer registered with FDA
Univy Technology Advanced Co. Ltd
Shanghai, China. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 225 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Univy Technology Advanced 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 | Univy Technology Advanced Co. Ltd | 8 device types | — | Below |
| Brazil | ANVISA | Manufacturer | UNIVY TECHNOLOGY ADVANCED CO., LTD | 25 | 2022–2026 | 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 Univy Technology Advanced 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 arch wire | 2023 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Buccal tubes | 2023 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Orthodontic elastic | 2023 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic metal brackets | 2023 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Root canal file | 2023 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | Niti engine file | 2023 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic Plier | 2025 |
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 |
|---|---|---|
| UNIVY TECHNOLOGY ADVANCED CO. LTDFDA reg. 3027343382 | Shanghai, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087835). 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.