Manufacturer registered with FDA
Shanghai Coherz Technologies Co., Ltd.
Shanghai, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 56 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Shanghai Coherz Technologies 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 | Shanghai Coherz Technologies Co., Ltd. | 2 device types | — | Below |
| Australia | TGA | Manufacturer | Shanghai Coherz Technologies Co Ltd | 2 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Shanghai Coherz Technologies Co., Ltd. | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shanghai Coherz Technologies Co., Ltd. | 1 | 2025–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Shanghai Coherz Technologies Co., Ltd. | 1 | — | 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 Shanghai Coherz Technologies 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 | MOLEKUR Bright T,MOLEKUR Pro S lite, MOLEKUR One S, MOLEKUR One S+, MOLEKUR One H, MOLEKUR Nova,MOLEKUR Express, MOLEKUR One, MOLEKUR Pro Eco, MOLEKUR Pro S, MOLEKUR Pro S+, MOLEKUR Pro Max, MOLEKUR Pro Max+,MOLEKUR Template E, MOLEKUR Template U, MOLEKUR Pro Neo | 2022 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Dental Foil, Model Resin | 2021 |
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 |
|---|---|---|
| Shanghai Coherz Technologies Co., Ltd.FDA reg. 3021610873 | Shanghai, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083911). 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.