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 |