The following data is part of a premarket notification filed by Dmi Innovative Medical Technology Ltd. with the FDA for Dmi Dental Implant System.
| Device ID | K160060 |
| 510k Number | K160060 |
| Device Name: | DMi Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DMi Innovative Medical Technology Ltd. 84 Sokolov St, Holon, IL 58330 |
| Contact | Yaniv Haim Buchacho |
| Correspondent | Eilat Ezra Duet Medical Consulting Ltd. 10 Haanafa St. P.O. Box 536 Zur-moshe, IL 42810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-12 |
| Decision Date | 2016-10-03 |