Manufacturer registered with FDA
DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd.
ZHANGZHOU, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name DEPRAG High tech Materials ( Zhengzhou ) 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 | DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. | 6 device types | — | Below |
| European Union | EUDAMED | Manufacturer | DEPRAG High tech Materials ( Zhengzhou ) 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 DEPRAG High tech Materials ( Zhengzhou ) 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-CeramicDental Zirconia Ceramic | 2024 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Diamond burs | 2025 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Dental Model MaterialsLight Cure Composite Resin | 2025 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | Firing paste | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | NiTi-File | 2025 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Synthetic resin teeth | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Fuzhou Rick Brown Biomaterials Co. Ltd. (1), Zirdent New Material Co.,Ltd (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Jul 2023 | K230487 | Dental Lithium Disilicate Glass-Ceramic | Fuzhou Rick Brown Biomaterials Co. Ltd. | EIH Porcelain Powder |
| 12 Nov 2021 | K212259 | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Zirdent New Material Co.,Ltd | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DEPRAG HIGH TECH MATERIALS ( ZHENGZHOU ) CO.,LTD.FDA reg. 3034729565 | ZHANGZHOU Henan, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092180). 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.