Data / Medical devices / China / Shenzhen Yurucheng Dental Materials Co., Ltd.
Shenzhen Yurucheng Dental Materials Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Shenzhen Yurucheng Dental Materials Co., Ltd. is registered with the FDA (registration 3022082678) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022082678
- Address
- Room 101,201,301,401,501, Bldg. 4, YESUN Life & Health Tech Park, No.19 Linhui Rd., Kengzi St., Pingshan Dist., Shenzhen Guangdong, China, 518118
- Owner or operator
- Shenzhen Yurucheng Dental Materials Co., Ltd. (10084571)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 7, 2022
- Registered through
- 2026
- Brand names listed
- Burs, Complete Denture, Zirconia full zirconia crown (bridge, post core, veneer, inlay), Complete Denture, upper implant cobalt-chromium photocurable composite resin crown (bridge); Ubest, Complete Denture,, Complete Denture, upper zirconia full zirconia crown (bridge); Ubest,, Complete Denture, zirconia full porcelain crown (bridge, veneer); Ubest,, Dental Glass Ceramics, Dental Lithium Disilicate Glass-Ceramics, Dental Zirconia Pre-shaded Block and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Dentures, Full | NSL | N | Exporter to the US | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Exporter to the US | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Exporter to the US | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 21, 2023 | K233016 | Dental Glass Ceramics | EIH | Substantially Equivalent | Shenzhen Yurucheng Dental Materials Co., Ltd. | accessdata.fda.gov |
| February 18, 2022 | K214005 | Zirconia Dental Ceramics | EIH | Substantially Equivalent | Shenzhen Yurucheng Dental Materials Co., Ltd. | accessdata.fda.gov |
| February 18, 2022 | K214003 | Dental Zirconia Pre-shaded Block | EIH | Substantially Equivalent | Shenzhen Yurucheng Dental Materials Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dentures, Partial
- All makers of Powder, Porcelain
- All makers of Bur, Dental
- All makers of Restoration, Porcelain
- All makers of Dentures, Full
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Updated December 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.