Denpac Corp.
United StatesFDA applicant, unverified
- Devices
- 4
What Denpac Corp. makes
Denpac Corp. manufactures dental materials, including a porcelain glaze system for restorative dentistry, a sintering alloy for dental prosthetics, a temporary dental liner, and a porcelain polishing compound for finishing dental restorations.
These products are regulated as Class II medical devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Composi-Glaze Ref K831484
Regimes: 510(k) Registry: 510(k)Sinterloy Ref K873373
Regimes: 510(k) Registry: 510(k)Dentaleen Ref K791160
Regimes: 510(k) Registry: 510(k)Save-A-Bake Porcelain Polish Ref K831483
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Denpac Corp. have in the registry?
The registry currently lists 4 devices for Denpac Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Denpac Corp.'s devices?
Among its 4 most recently registered devices, Denpac Corp. has devices listed in FDA 510(k) (4 devices).
What risk classes do Denpac Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Denpac Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Denpac Corp. in the registry?
The most recently registered devices listed for Denpac Corp. include COMPOSI-GLAZE, SINTERLOY, DENTALEEN and SAVE-A-BAKE PORCELAIN POLISH.