The following data is part of a premarket notification filed by Medical Systems And Devices International Ltd. with the FDA for Msdi Dental Implants System.
| Device ID | K191443 | 
| 510k Number | K191443 | 
| Device Name: | MSDI Dental Implants System | 
| Classification | Implant, Endosseous, Root-form | 
| Applicant | Medical Systems And Devices International Ltd. Ba'alei Hamalaha 26 Haifa, IL 3223020 | 
| Contact | Iman Khorshid | 
| Correspondent | Iman Khorshid QRS Industrial Park Tefen Tefen, IL 2495900 | 
| Product Code | DZE | 
| CFR Regulation Number | 872.3640 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2019-05-30 | 
| Decision Date | 2020-06-26 |