Duradent Corp.
Country not established
- Devices
- 1
What Duradent Corp. makes
Duradent Corp. manufactures the DistaFlex, a dental device designed for intraoral use in orthodontic applications, likely for aligning or stabilizing teeth.
The DistaFlex is classified as a Class I medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Distaflex Ref K823280
510(k) 510(k)
Frequently asked questions
How many devices does Duradent Corp. have in the registry?
The registry currently lists 1 device for Duradent Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Duradent Corp.'s devices?
Among its 1 most recently registered device, Duradent Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Duradent Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Duradent Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Duradent Corp. in the registry?
The most recently registered devices listed for Duradent Corp. include DISTAFLEX.