The following data is part of a premarket notification filed by Dental Evolutions Inc. with the FDA for Implanova.
| Device ID | K210523 |
| 510k Number | K210523 |
| Device Name: | Implanova |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Dental Evolutions Inc. 9100 Wilshire Blvd Ste 448W Beverly Hills, CA 90212 |
| Contact | Matthew Mineros |
| Correspondent | Raymond Kelly Arazy Group 3422 Leonardo Lane New Smyrna Beach, FL 32168 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-23 |
| Decision Date | 2021-09-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IMPLANOVA 85383477 4422373 Live/Registered |
Zadeh, Parsa T. 2011-07-28 |