Baladent
Country not established
- Devices
- 1
What Baladent makes
Baladent manufactures the SeaLex Extra root canal sealer, a material designed for filling and sealing root canal spaces during endodontic procedures.
The SeaLex Extra root canal sealer is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Sealex Extra Root Canal Sealer Ref K962885
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Baladent have in the registry?
The registry currently lists 1 device for Baladent. Devices recorded under merged duplicate company entries are counted once.
Which registries list Baladent's devices?
Among its 1 most recently registered device, Baladent has devices listed in FDA 510(k) (1 device).
What risk classes do Baladent's devices fall under?
Among its 1 most recently registered device, the classes recorded for Baladent's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Baladent in the registry?
The most recently registered devices listed for Baladent include SEALEX EXTRA ROOT CANAL SEALER.