The following data is part of a premarket notification filed by Cortex Dental Implants Industries Ltd. with the FDA for Cortex Cad/cam Abutments.
| Device ID | K181580 |
| 510k Number | K181580 |
| Device Name: | Cortex CAD/CAM Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Cortex Dental Implants Industries Ltd. Shlomi Industrial Estate Shlomi, IL 22832 |
| Contact | Ronit Polack |
| Correspondent | Raymond Kelly Licensale Inc 68 Southwoods Terrace Southbury, CT 06488 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-15 |
| Decision Date | 2019-01-29 |