The following data is part of a premarket notification filed by Dental Evolutions Inc. with the FDA for Implanova.
Device ID | K150040 |
510k Number | K150040 |
Device Name: | Implanova |
Classification | Implant, Endosseous, Root-form |
Applicant | DENTAL EVOLUTIONS INC. 9100 WILSHIRE BLVD. SUITE W448 Beverly Hills, CA 90212 |
Contact | Parsa T Zadeh |
Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-09 |
Decision Date | 2015-08-27 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IMPLANOVA 85383477 4422373 Live/Registered |
Zadeh, Parsa T. 2011-07-28 |