Spectrum Healthcare Group
Country not established
- Devices
- 1
What Spectrum Healthcare Group makes
Spectrum Healthcare Group manufactures intraoral scanners, including the OptoDent and OptoGnath, which capture detailed digital impressions of dental anatomy for restorative and orthodontic planning.
These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearance. The company is based in the United States.
Catalogue
Optodent/Optognath Ref K936058
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spectrum Healthcare Group have in the registry?
The registry currently lists 1 device for Spectrum Healthcare Group. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spectrum Healthcare Group's devices?
Among its 1 most recently registered device, Spectrum Healthcare Group has devices listed in FDA 510(k) (1 device).
What risk classes do Spectrum Healthcare Group's devices fall under?
Among its 1 most recently registered device, the classes recorded for Spectrum Healthcare Group's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spectrum Healthcare Group in the registry?
The most recently registered devices listed for Spectrum Healthcare Group include OPTODENT/OPTOGNATH.