Manufacturer registered with FDA
Wuhu Guli Ortho Co.,Ltd
Wuhu, China. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 17
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Wuhu Guli Ortho 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 | Wuhu Guli Ortho Co.,Ltd | 12 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | WUHU GULI ORTHO CO., LTD, | 3 | — | 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 Wuhu Guli Ortho 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 Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Orthodontic retainer screw expansionOrthodontic universal lingual retainers | 2021 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | Orthodontic bands | 2021 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic wire | 2021 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Orthodontic buccal tube | 2021 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Orthodontic bands | 2021 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Orthodontic elastomeric auxiliaries | 2021 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Orthodontic spring | 2021 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Orthodontic wax | 2021 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic bracketOrthodontic crimpable hooksOrthodontic invisible bracketOrthodontic lingual buttonOrthodontic lingual sheath | 2021 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Dental root canal instruments | 2021 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic plier | 2021 |
| Karaya Denture AdhesiveKOP · Class 1 | — | Maker | Orthodontic Bonding | 2023 |
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 |
|---|---|---|
| WUHU GULI ORTHO CO.,LTDFDA reg. 3017953780 | Wuhu Anhui, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10079999). 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.