Manufacturer registered with FDA
Shenzhen Yurucheng Dental Materials Co., Ltd.
Shenzhen, China. Lists 3 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 10
- 510(k) clearances
- 32022–2023
- Markets registered in
- 87,081 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Shenzhen Yurucheng 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 | Shenzhen Yurucheng Dental Materials Co., Ltd. | 3 clearances | 2022–2023 | Below |
| European Union | EUDAMED | Manufacturer | Shenzhen Yurucheng Dental Materials Co., Ltd. | 7,064 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHENZHEN YURUCHENG DENTAL MATERIALS CO., LTDSHENZHEN YURUCHENG DENTAL MATERIALS CO., LTD. | 10 | 2023–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Shenzhen Yurucheng Dental Materials Co Ltd | 2 | 2023–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | SHENZHEN YURUCHENG DENTAL MATERIALS CO., LTD. | 2 | 2025–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Shenzhen Yurucheng Dental Materials Co,. Ltd | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shenzhen Yurucheng Dental Materials Co., Ltd., | 1 | 2021–2021 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Shenzhen Yurucheng Dental Materials Co., Ltd. | 1 | 2022–2022 | 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 Shenzhen Yurucheng 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Dental Glass CeramicsDental Lithium Disilicate Glass-CeramicsDental Zirconia Pre-shaded BlockGUSROMLithium DisilicateZirconia Dental Ceramics | 2022 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | BursGUSROM | 2026 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | GUSROMIntraoral Scanner ,YRC-S03 | 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 Shenzhen Yurucheng Dental Materials Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Dec 2023 | K233016 | Dental Glass Ceramics | EIH Porcelain Powder |
| 18 Feb 2022 | K214005 | Zirconia Dental Ceramics | EIH Porcelain Powder |
| 18 Feb 2022 | K214003 | Dental Zirconia Pre-shaded Block | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Digital Arches Inc. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHENZHEN YURUCHENG DENTAL MATERIALS CO., LTD.FDA reg. 3022082678 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084571). 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.