The following data is part of a premarket notification filed by Implant Microdent with the FDA for Microdent Genius Implant System.
| Device ID | K141188 |
| 510k Number | K141188 |
| Device Name: | MICRODENT GENIUS IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT MICRODENT 144 RESEARCH DRIVE Hampton, VA 23666 |
| Contact | Rhonda Alexander |
| Correspondent | Rhonda Alexander IMPLANT MICRODENT 144 RESEARCH DRIVE Hampton, VA 23666 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-08 |
| Decision Date | 2015-06-02 |
| Summary: | summary |