Enpuno Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 1
What Enpuno Co., Ltd. makes
Enpuno Co., Ltd. manufactures an injectable root canal bioceramic sealer, specifically the nRoot SP, designed for dental applications to seal root canals during endodontic procedures.
The company’s portfolio is regulated under FDA Class II devices and is listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Enpuno Co., Ltd. have in the registry?
The registry currently lists 1 device for Enpuno Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Enpuno Co., Ltd.'s devices?
Among its 1 most recently registered device, Enpuno Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Enpuno Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Enpuno Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Enpuno Co., Ltd. in the registry?
The most recently registered devices listed for Enpuno Co., Ltd. include Injectable Root Canal Bioceramic Sealer (nRoot SP).