The following data is part of a premarket notification filed by Mis Implants Technologies Ltd. with the FDA for Mis V3 Conical Connection Dental Implant System.
| Device ID | K163349 |
| 510k Number | K163349 |
| Device Name: | MIS V3 Conical Connection Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park Bar Lev Industrial Park, IL 2015600 |
| Contact | Arbel Shezaf |
| Correspondent | Arbel Shezaf MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park Bar Lev Industrial Park, IL 2015600 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-29 |
| Decision Date | 2017-05-26 |
| Summary: | summary |