United Zirconia
EgyptFDA 510(k) applicant, unverified
- Devices
- 1
What United Zirconia makes
United Zirconia manufactures dental restorative materials, specifically zirconia-based crowns and bridges under the ZircaGlow and ZircaGlow HT brands. These products are designed for dental applications requiring high-strength, biocompatible ceramic restorations.
The company’s portfolio is regulated under FDA Class II devices and is listed via 510(k) clearance in the United States. The products are developed and distributed from the company’s base in the US.
Catalogue
ZircaGlow & ZircaGlow HT Zirconia Ref K250393
510(k) 510(k)
Frequently asked questions
How many devices does United Zirconia have in the registry?
The registry currently lists 1 device for United Zirconia. Devices recorded under merged duplicate company entries are counted once.
Which registries list United Zirconia's devices?
Among its 1 most recently registered device, United Zirconia has devices listed in FDA 510(k) (1 device).
What risk classes do United Zirconia's devices fall under?
Among its 1 most recently registered device, the classes recorded for United Zirconia's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from United Zirconia in the registry?
The most recently registered devices listed for United Zirconia include ZircaGlow & ZircaGlow HT Zirconia.