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 | K041236 |
| 510k Number | K041236 |
| 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 | 2004-05-11 |
| Decision Date | 2004-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747099591 | K041236 | 000 |
| 07332747099430 | K041236 | 000 |
| 07332747099423 | K041236 | 000 |
| 07332747099416 | K041236 | 000 |
| 07332747099409 | K041236 | 000 |
| 07332747099393 | K041236 | 000 |
| 07332747099386 | K041236 | 000 |
| 07332747099379 | K041236 | 000 |
| 07332747099362 | K041236 | 000 |
| 07332747099355 | K041236 | 000 |
| 07332747099348 | K041236 | 000 |
| 07332747099331 | K041236 | 000 |
| 07332747099324 | K041236 | 000 |
| 07332747099447 | K041236 | 000 |
| 07332747099454 | K041236 | 000 |
| 07332747099461 | K041236 | 000 |
| 07332747099584 | K041236 | 000 |
| 07332747099577 | K041236 | 000 |
| 07332747099560 | K041236 | 000 |
| 07332747099553 | K041236 | 000 |
| 07332747099546 | K041236 | 000 |
| 07332747099539 | K041236 | 000 |
| 07332747099522 | K041236 | 000 |
| 07332747099515 | K041236 | 000 |
| 07332747099508 | K041236 | 000 |
| 07332747099492 | K041236 | 000 |
| 07332747099485 | K041236 | 000 |
| 07332747099478 | K041236 | 000 |
| 07332747069716 | K041236 | 000 |