Manufacturer registered with FDA
Dongguan Hengrui Silicone Products Co., Ltd.
Dongguan, 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
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Dongguan Hengrui Silicone Products 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 | Dongguan Hengrui Silicone Products Co., Ltd. | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Dongguan Hengrui Silicone Products 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 Dongguan Hengrui Silicone Products 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 Wire ClampECN · Class 1 | — | Maker | Removal tool | 2023 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | Aligner Chewies | 2023 |
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 |
|---|---|---|
| DONGGUAN HENGRUI SILICONE PRODUCTS CO., LTD.FDA reg. 3030234169 | Dongguan Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089351). 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.