Ensmile Pvt, Ltd.
PakistanFDA applicant, unverified
- Devices
- 1
What Ensmile Pvt, Ltd. makes
Ensmile Pvt, Ltd. manufactures dental devices, including orthodontic aligners designed for tooth alignment and correction.
The company’s portfolio is regulated under FDA Class II devices, with products listed via the 510(k) pathway. Ensmile Pvt, Ltd. is based in the United States.
Catalogue
Ensmile Ref K222619
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ensmile Pvt, Ltd. have in the registry?
The registry currently lists 1 device for Ensmile Pvt, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ensmile Pvt, Ltd.'s devices?
Among its 1 most recently registered device, Ensmile Pvt, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Ensmile Pvt, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ensmile Pvt, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ensmile Pvt, Ltd. in the registry?
The most recently registered devices listed for Ensmile Pvt, Ltd. include Ensmile.