Manufacturer registered with FDA
Hansfive (Hangzhou) Dental Technology Co., Ltd.
Hangzhou city, China. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Hansfive (Hangzhou) Dental Technology 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 | Hansfive (Hangzhou) Dental Technology Co., Ltd. | 7 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Hansfive (Hangzhou) Dental Technology Co., Ltd. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Hansfive (Hangzhou) Dental Technology Co., Ltd. | 1 | 2026–2026 | 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 Hansfive (Hangzhou) Dental Technology 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 Wire | 2025 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Buccal Tubes | 2025 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Band | 2025 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Crimpable HookLingual Button | 2025 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Spring | 2025 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic Brackets | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Nickel Titanium Root Canal File | 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 |
|---|---|---|
| Hansfive (Hangzhou) Dental Technology Co.,LtdFDA reg. 3027520354 | Hangzhou city Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088065). 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.