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 |