U.S. Shizai Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 7
What U.S. Shizai Corp. makes
U.S. Shizai Corp. makes dental devices, including obturation systems and materials like gutta percha, as well as alloys and sonic devices for dental procedures. Their products include the DENTLOID, OBTURATION SYSTEM KIT, CASTA-LLOY, HARMO SONIC, and OBTURATION GUTTA.
The company's portfolio is regulated under Class I and Class II devices and is listed in the FDA 510(k) registry. U.S. Shizai Corp. is based in the United States.
Catalogue
Dentloid Ref K802189
510(k) 510(k)Fr Root Canal Sealer Ref K830764
510(k) 510(k)Obturation System Kit Ref K820639
510(k) 510(k)Casta-Lloy Ref K800951
510(k) 510(k)Harmo Sonic Ref K853841
510(k) 510(k)Fr Root Canal Filler Ref K830763
510(k) 510(k)Obturation Gutta Ref K822464
510(k) 510(k)
Frequently asked questions
How many devices does U.S. Shizai Corp. have in the registry?
The registry currently lists 7 devices for U.S. Shizai Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list U.S. Shizai Corp.'s devices?
Among its 7 most recently registered devices, U.S. Shizai Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do U.S. Shizai Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for U.S. Shizai Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from U.S. Shizai Corp. in the registry?
The most recently registered devices listed for U.S. Shizai Corp. include DENTLOID, FR ROOT CANAL SEALER, OBTURATION SYSTEM KIT and CASTA-LLOY.