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 |