Data / Medical devices / United States / Yucera Healthcare Tech Usa Inc
Yucera Healthcare Tech Usa Inc: FDA-registered device maker in Ontario, CA, United States, 3 510(k) clearances
Yucera Healthcare Tech Usa Inc is registered with the FDA (registration 3042370495) in Ontario, CA, United States. It lists 1 device type. 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
- 3042370495
- Address
- 3100 E Cedar ST, Unit 17, Ontario, CA, United States, 91761
- Owner or operator
- Yucera Healthcare Tech USA INC (10094232)
- Roles
- Complaint file establishment
- First device listed
- November 19, 2025
- Registered through
- 2026
- Brand names listed
- Dental Glass Ceramics, Dental Zirconia Pre-shaded Block, Zirconia Dental Ceramics
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Complaint file establishment | 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
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.