The following data is part of a premarket notification filed by Noris Medical Ltd. with the FDA for Noris Medical Mbi Dental Implant System.
| Device ID | K153043 |
| 510k Number | K153043 |
| Device Name: | Noris Medical MBI Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NORIS MEDICAL LTD. 8 HATAASIA Nesher, IL 3688808 |
| Contact | Simha Sibony |
| Correspondent | Simha Sibony NORIS MEDICAL LTD. 8 HATAASIA Nesher, IL 3688808 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-19 |
| Decision Date | 2016-04-11 |