The following data is part of a premarket notification filed by Cortex Dental Implants Industries Ltd. with the FDA for Cortex Dental Implant System.
| Device ID | K163385 |
| 510k Number | K163385 |
| Device Name: | Cortex Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Cortex Dental Implants Industries Ltd. Shlomi Industrial Estate Shlomi, IL 22832 |
| Contact | Michal Yeger |
| Correspondent | Raymond Kelly Licensale Inc. 68 Southwoods Terrace Southbury, CT 06488 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-02 |
| Decision Date | 2017-08-29 |