Denx Advanced Dental Systems
IsraelFDA applicant, unverified
- Devices
- 2
What Denx Advanced Dental Systems makes
Denx Advanced Dental Systems manufactures the IGI-System, a dental imaging device designed for intraoral scanning and digital impression capture used in restorative and orthodontic procedures.
The IGI-System is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Igi-System Ref K023424
Regimes: 510(k) Registry: 510(k)Igi-System Ref K052840
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Denx Advanced Dental Systems have in the registry?
The registry currently lists 2 devices for Denx Advanced Dental Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Denx Advanced Dental Systems's devices?
Among its 2 most recently registered devices, Denx Advanced Dental Systems has devices listed in FDA 510(k) (2 devices).
What risk classes do Denx Advanced Dental Systems's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Denx Advanced Dental Systems's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Denx Advanced Dental Systems in the registry?
The most recently registered devices listed for Denx Advanced Dental Systems include IGI-SYSTEM.