The following data is part of a premarket notification filed by Nobelbiocare Ab with the FDA for Nobelactive Wide Platform (wp).
| Device ID | K133731 |
| 510k Number | K133731 |
| Device Name: | NOBELACTIVE WIDE PLATFORM (WP) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBELBIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Phuong Nguyen |
| Correspondent | Phuong Nguyen NOBELBIOCARE AB 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 | 2013-12-06 |
| Decision Date | 2014-05-08 |
| Summary: | summary |