Manufacturer registered with FDA
Changzhou Hongtai Paper Film Co Ltd
Changzhou, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 411 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Changzhou Hongtai Paper Film 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 | Changzhou Hongtai Paper Film Co Ltd | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Changzhou Hongtai Paper Film Co.,Ltd | 7 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Changzhou Hongtai Paper Film Co., Ltd | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Changzhou Hongtai Paper Film Co Ltd | 1 | 2020–2020 | 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 Changzhou Hongtai Paper Film 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | SALIVA EJECTORS | 2026 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Dental Bib | 2014 |
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 |
|---|---|---|
| CHANGZHOU HONGTAI PAPER FILM CO., LTDFDA reg. 3011091529 | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047188). 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.