Data / Medical devices / China / Topzir Biotech Co., Ltd
Topzir Biotech Co., Ltd: FDA-registered device maker in Guangzhou Guangdong, China, 1 510(k) clearance
Topzir Biotech Co., Ltd is registered with the FDA (registration 3027341558) in Guangzhou Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 31, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3027341558
- Address
- Room 520, Creative Center, No.69, Guangpu West Road, Huangpu District, Guangzhou Guangdong, China, 510663
- Owner or operator
- Topzir Biotech Co., Ltd (10087795)
- Roles
- Manufacturer
- First device listed
- April 10, 2023
- Registered through
- 2026
- Brand names listed
- 4D Ultra Fit Multilayer, 3D Pro Ultra Multilayer, Topzir 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 |
|---|---|---|---|---|---|---|
| March 31, 2023 | K230003 | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | EIH | Substantially Equivalent | Topzir Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 31, 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.