The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052.
| Device ID | K043042 |
| 510k Number | K043042 |
| Device Name: | PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Elizabeth J Mason |
| Correspondent | Elizabeth J Mason NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. 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 | 2004-11-04 |
| Decision Date | 2004-11-18 |
| Summary: | summary |