Manufacturer registered with FDA
Fuzhou Rick Brown Biomaterials Co. Ltd.
Fuzhou, China. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 1
- 510(k) clearances
- 12023–2023
- Markets registered in
- 68 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Fuzhou Rick Brown Biomaterials 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 | Fuzhou Rick Brown Biomaterials Co. Ltd. | 1 clearances | 2023–2023 | Below |
| Australia | TGA | Manufacturer | Fuzhou Rick Brown Biomaterials Co Ltd | 2 | 2025–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | FUZHOU RICK BROWN BIOMATERIALS CO LTD | 2 | 2024–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Fuzhou Rick Brown Biomaterials Co., Ltd. | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Fuzhou Rick Brown Biomaterials Co., Ltd. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Fuzhou Rick Brown Biomaterials Co., Ltd. | 1 | 2025–2025 | 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 Fuzhou Rick Brown Biomaterials 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Dental Lithium Disilicate Glass-Ceramic | 2023 |
| Carboxymethylcellulose Sodium (49%) and Ethylene-Oxide Homopolymer Denture AdhesiveKXW · Class 1 | — | Maker | — | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Fuzhou Rick Brown Biomaterials Co. Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Jul 2023 | K230487 | Dental Lithium Disilicate Glass-Ceramic | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FUZHOU RICK BROWN BIOMATERIALS CO. LTD.FDA reg. 3029968429 | Fuzhou Fujian, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088829). 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.