Trans-Atlantic Dental
Country not established
- Devices
- 1
What Trans-Atlantic Dental makes
Trans-Atlantic Dental manufactures dental restorative materials, including the UNI-FLEX RESIN, a composite resin designed for dental fillings and restorations. This product is intended for use in direct and indirect dental applications, providing durable and aesthetically pleasing repairs.
The company’s portfolio is regulated under Class II medical devices in the United States, with individual products authorised through the FDA’s 510(k) clearance process. The manufacturer operates from the US, adhering to applicable regulatory standards for dental materials.
Catalogue
Uni-Flex Resin Ref K983461
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Trans-Atlantic Dental have in the registry?
The registry currently lists 1 device for Trans-Atlantic Dental. Devices recorded under merged duplicate company entries are counted once.
Which registries list Trans-Atlantic Dental's devices?
Among its 1 most recently registered device, Trans-Atlantic Dental has devices listed in FDA 510(k) (1 device).
What risk classes do Trans-Atlantic Dental's devices fall under?
Among its 1 most recently registered device, the classes recorded for Trans-Atlantic Dental's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Trans-Atlantic Dental in the registry?
The most recently registered devices listed for Trans-Atlantic Dental include UNI-FLEX RESIN.