Manufacturer registered with FDA
ChangShu ShangChi Dental Materials Co., Ltd.
Changshu, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name ChangShu ShangChi Dental Materials 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 | ChangShu ShangChi Dental Materials Co., Ltd. | 3 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Changshu Shangchi Dental Materials 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 ChangShu ShangChi Dental Materials 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 |
|---|---|---|---|---|
| Intraoral Dental WaxEGD · Class 1 | — | Maker | DENTAL WAX | 2025 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | Dental Alloy Series | 2024 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | Zinc Oxide Eugenol Cement | 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 |
|---|---|---|
| CHANGSHU SHANGCHI DENTAL MATERIALS CO., LTD.FDA reg. 3015542306 | Changshu Jiangsu, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090946). 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.