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 | K090709 |
| 510k Number | K090709 |
| Device Name: | CORTEX DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CORTEX DENTAL IMPLANTS INDUSTRIES, LTD INDUSTRIAL PARK 13 Mizpe Aviv, M.p. Misgav, IL 20187 |
| Contact | Benny Azary |
| Correspondent | Benny Azary CORTEX DENTAL IMPLANTS INDUSTRIES, LTD INDUSTRIAL PARK 13 Mizpe Aviv, M.p. Misgav, IL 20187 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-18 |
| Decision Date | 2009-07-07 |
| Summary: | summary |