The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004.
| Device ID | K042658 |
| 510k Number | K042658 |
| Device Name: | PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Elizabeth J Mason |
| Correspondent | Elizabeth J Mason NOBEL BIOCARE UAS INC 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 | 2004-09-28 |
| Decision Date | 2004-10-20 |
| Summary: | summary |