The following data is part of a premarket notification filed by Nobel Biocare Usa, Llc with the FDA for Nobelprocera Overdenture Bar.
| Device ID | K132749 |
| 510k Number | K132749 |
| Device Name: | NOBELPROCERA OVERDENTURE BAR |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE USA, LLC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Phuong Nguyen Son |
| Correspondent | Phuong Nguyen Son NOBEL BIOCARE USA, LLC 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 | 2013-09-03 |
| Decision Date | 2014-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747080858 | K132749 | 000 |
| 07332747079760 | K132749 | 000 |
| 07332747079777 | K132749 | 000 |
| 07332747079784 | K132749 | 000 |
| 07332747079791 | K132749 | 000 |
| 07332747080803 | K132749 | 000 |
| 07332747080810 | K132749 | 000 |
| 07332747080827 | K132749 | 000 |
| 07332747080834 | K132749 | 000 |
| 07332747080841 | K132749 | 000 |
| 07332747079753 | K132749 | 000 |