Manufacturer registered with FDA
Bazhou City Xin an Town Hexin Medical Material Factory
HEBEI PROVINCE, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Bazhou City Xin an Town Hexin Medical Material Factory 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 | Bazhou City Xin an Town Hexin Medical Material Factory | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | Bazhou City Xin’an Town Hexin Medical Material Factory | 1 | 2024–2024 | 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 Bazhou City Xin an Town Hexin Medical Material Factory currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points | 1999 |
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 |
|---|---|---|
| Bazhou City Xin an Town Hexin Medical Material FactoryFDA reg. 9681750 | Hebei Province, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9026919). 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.