The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelactive.
Device ID | K142260 |
510k Number | K142260 |
Device Name: | NobelActive |
Classification | Implant, Endosseous, Root-form |
Applicant | NOBEL BIOCARE AB VASTRA HAMNGATAN 1 Goteborg, SE Se-411 17 |
Contact | Phuong Nguyen Son |
Correspondent | Ji Eun Hwang NOBEL BIOCARE USA, LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-14 |
Decision Date | 2015-05-11 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NOBELACTIVE 79060037 3635600 Live/Registered |
Nobel Biocare Services AG 2008-07-15 |