Dmi Innovative Medical Technology, Ltd.
IsraelFDA applicant, unverified
- Devices
- 10
What Dmi Innovative Medical Technology, Ltd. makes
Dmi Innovative Medical Technology, Ltd. manufactures the DMi Dental Implant System, a solution designed for dental restoration through osseointegrated implants in the jawbone. The system includes components for surgical placement, abutments, and prosthetic attachments to support crowns, bridges, or dentures. It is intended for use in both anterior and posterior regions of the mouth, providing fixed or removable dental solutions for patients with missing teeth.
The DMi Dental Implant System is classified as a Class II medical device under FDA regulations and requires a 510(k) clearance for market authorisation in the United States. The company is based in the US and its products are listed in the FDA’s 510(k) registry. No additional regulatory bodies or classifications are referenced for this device.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
DMi Dental Implant System Ref K160060
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 649187788
- [email protected]
- Phone
- +1 917 2798318
Frequently asked questions
How many devices does Dmi Innovative Medical Technology, Ltd. have in the registry?
The registry currently lists 10 devices for Dmi Innovative Medical Technology, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dmi Innovative Medical Technology, Ltd.'s devices?
Among its 10 most recently registered devices, Dmi Innovative Medical Technology, Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Dmi Innovative Medical Technology, Ltd.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Dmi Innovative Medical Technology, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dmi Innovative Medical Technology, Ltd. in the registry?
The most recently registered devices listed for Dmi Innovative Medical Technology, Ltd. include Prima Titanium Implant 5.0mmd/8mml, Prima Titanium Implant 4.2mmd/8mml, Prima Titanium Implant 3.75mmd/8mml and Prima Titanium Implant 5.0mmd/10mml.