Pro-Den Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Pro-Den Systems, Inc. makes
Pro-Den Systems, Inc. manufactures the POLY-LITE Model 1000, a dental curing light designed for polymerizing composite restorative materials, and the PRO-SCOPE Model PS-4000, an intraoral dental examination camera for capturing high-resolution images of oral structures.
The company’s products are regulated under FDA’s 510(k) pathway, with the POLY-LITE Model 1000 classified as Class I and the PRO-SCOPE Model PS-4000 as Class II. Both devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Poly-Lite Model 1000 Ref K954061
Regimes: 510(k) Registry: 510(k)Pro-Scope Model # Ps-4000 Ref K922942
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pro-Den Systems, Inc. have in the registry?
The registry currently lists 2 devices for Pro-Den Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pro-Den Systems, Inc.'s devices?
Among its 2 most recently registered devices, Pro-Den Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Pro-Den Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pro-Den Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pro-Den Systems, Inc. in the registry?
The most recently registered devices listed for Pro-Den Systems, Inc. include POLY-LITE MODEL 1000 and PRO-SCOPE MODEL # PS-4000.