Data / Medical devices / China / Zirdent New Material Co.,ltd
Zirdent New Material Co.,ltd: FDA-registered device maker in Changsha Hunan, China, 1 510(k) clearance
Zirdent New Material Co.,ltd is registered with the FDA (registration 3021284321) in Changsha Hunan, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 12, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021284321
- Address
- 1st & 2nd floor, Building 5, Changsha Medical device Industrial Area,No.88, Section 1,Tengfei Road Wangcheng Economic and Technological Development Zone, Changsha Hunan, China, 410200
- Owner or operator
- Zirdent New Material Co.,Ltd (10083428)
- Roles
- Manufacturer
- First device listed
- November 18, 2021
- Registered through
- 2026
- Brand names listed
- Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Zirconia Blocks, Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 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 |
|---|---|---|---|---|---|---|
| November 12, 2021 | K212259 | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | EIH | Substantially Equivalent | Zirdent New Material Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 12, 2021. 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.