Dental Systems.Com, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Dental Systems.Com, Inc. makes
Dental Systems.Com, Inc. manufactures dental curing devices, including the COOLBLU2 and COOLBLU curing lights, which are designed for polymerizing composite resins in dental restorations.
These devices fall under FDA Class II regulation and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
COOLBLU2 Dental Resin Curing Device Ref K020171
Regimes: 510(k) Registry: 510(k)Coolblu Curing Light Ref K002925
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dental Systems.Com, Inc. have in the registry?
The registry currently lists 2 devices for Dental Systems.Com, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dental Systems.Com, Inc.'s devices?
Among its 2 most recently registered devices, Dental Systems.Com, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dental Systems.Com, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dental Systems.Com, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dental Systems.Com, Inc. in the registry?
The most recently registered devices listed for Dental Systems.Com, Inc. include COOLBLU2 DENTAL RESIN CURING DEVICE and COOLBLU CURING LIGHT.