The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelprocera Peek Abutments.
| Device ID | K120954 |
| 510k Number | K120954 |
| Device Name: | NOBELPROCERA PEEK ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Phuong Nguyen Son |
| Correspondent | Phuong Nguyen Son 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 | 2012-03-30 |
| Decision Date | 2013-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747014204 | K120954 | 000 |
| 07332747014198 | K120954 | 000 |
| 07332747014181 | K120954 | 000 |
| 07332747014143 | K120954 | 000 |
| 07332747009279 | K120954 | 000 |
| 07332747009262 | K120954 | 000 |
| 07332747009255 | K120954 | 000 |
| 07332747009248 | K120954 | 000 |