The following data is part of a premarket notification filed by Cortex Dental Implants Industries, Ltd with the FDA for Saturn Dental Implant.
| Device ID | K131258 |
| 510k Number | K131258 |
| Device Name: | SATURN DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CORTEX DENTAL IMPLANTS INDUSTRIES, LTD MOBILE POST ASHRAT Mobile Post Ashrat, IL 25201 |
| Contact | Simha Sibony |
| Correspondent | Simha Sibony CORTEX DENTAL IMPLANTS INDUSTRIES, LTD MOBILE POST ASHRAT Mobile Post Ashrat, IL 25201 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-02 |
| Decision Date | 2014-03-17 |
| Summary: | summary |