Topzir Biotech Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Topzir Biotech Co., Ltd. makes
Topzir Biotech Co., Ltd. manufactures dental zirconia blanks, including both standard and pre-shaded variants, designed for use in dental restorations such as crowns, bridges, and inlays. These products are intended for milling and fabrication in dental laboratories to create custom-fit restorative solutions for patients.
The company’s dental zirconia blanks are classified as Class II medical devices under FDA regulations and are subject to the 510(k) premarket notification process. These products are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA establishments
- Topzir Biotech Co., Ltd Guangzhou Guangdong · CN FEI 3027341558
Frequently asked questions
How many devices does Topzir Biotech Co., Ltd. have in the registry?
The registry currently lists 1 device for Topzir Biotech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Topzir Biotech Co., Ltd.'s devices?
Among its 1 most recently registered device, Topzir Biotech Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Topzir Biotech Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Topzir Biotech Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Topzir Biotech Co., Ltd. in the registry?
The most recently registered devices listed for Topzir Biotech Co., Ltd. include Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank.
Which FDA establishments are linked to Topzir Biotech Co., Ltd.?
1 FDA establishment is linked to Topzir Biotech Co., Ltd. in the registry; they are listed on the company page.