The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Procera Bridge Laminate, Model 40-4002.
| Device ID | K053068 |
| 510k Number | K053068 |
| Device Name: | PROCERA BRIDGE LAMINATE, MODEL 40-4002 |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Phuong Nguyen Son |
| Correspondent | Phuong Nguyen Son NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-01 |
| Decision Date | 2006-02-22 |
| Summary: | summary |