Nobel Biocare C/O Medicim NV
BelgiumFDA applicant, unverified FDA FEI 3005739655
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Nobel Biocare C/O Medicim NV makes
Nobel Biocare (operating under Medicim NV) manufactures the DTX Studio Assist, a dental imaging system designed for intraoral scanning and digital workflow integration in dental practices.
The DTX Studio Assist is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
DTX Studio Assist Ref K252086
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3005739655
- Address
- Stationsstraat 102, Mechelen Antwerpen
Frequently asked questions
How many devices does Nobel Biocare C/O Medicim NV have in the registry?
The registry currently lists 1 device for Nobel Biocare C/O Medicim NV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nobel Biocare C/O Medicim NV's devices?
Among its 1 most recently registered device, Nobel Biocare C/O Medicim NV has devices listed in FDA 510(k) (1 device).
What risk classes do Nobel Biocare C/O Medicim NV's devices fall under?
Among its 1 most recently registered device, the classes recorded for Nobel Biocare C/O Medicim NV's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nobel Biocare C/O Medicim NV in the registry?
The most recently registered devices listed for Nobel Biocare C/O Medicim NV include DTX Studio Assist.