Betta Dental, Inc.
Country not established
- Devices
- 1
What Betta Dental, Inc. makes
Betta Dental, Inc. manufactures the 1 STEP dental adhesive system, designed for bonding and luting applications in restorative dentistry. This product is intended for securing dental restorations such as crowns, bridges, and inlays/onlays to tooth structures.
The 1 STEP adhesive system is classified as a Class II medical device in the US and is authorised through the FDA 510(k) pathway. The company is based in the United States.
Catalogue
1 Step Ref K792003
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Betta Dental, Inc. have in the registry?
The registry currently lists 1 device for Betta Dental, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Betta Dental, Inc.'s devices?
Among its 1 most recently registered device, Betta Dental, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Betta Dental, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Betta Dental, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Betta Dental, Inc. in the registry?
The most recently registered devices listed for Betta Dental, Inc. include 1 STEP.