Topzir Biotech Co., Ltd.
Registered establishment in Guangzhou, Guangdong, China. 1 device type, 1 clearance.
Topzir Biotech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powder, Porcelain. Its earliest product listing with the FDA dates from 2023.
1device type
1510(k) clearance
Registration
| Registered name | TOPZIR BIOTECH CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3027341558 |
| FEI number | 3027341558 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广州拓普生物科技有限公司 |
|---|---|
| Source | Zhihuiya company database |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | Room 520, Creative Center, No.69, Guangpu West Road, Huangpu District |
| Postal code | 510663 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Powder, Porcelain | Class 2 | 4D Ultra Fit Multilayer, 3D Pro Ultra Multilayer, Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 2023 | 33 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230003 | 2023-03-31 | EIH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Employees | 201-300 |
| Main products | dental zirconia blocks, pre-shaded zirconia blocks, multilayer zirconia blocks, zirconia blanks |
| Certifications | FDA, CNAS |
| Export markets | 100+ countries (North America, South America, Europe, Asia, Africa, Middle East, Oceania) |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.