The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelactive 3.0 Goldadapt Abutments.
| Device ID | K112259 |
| 510k Number | K112259 |
| Device Name: | NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-08 |
| Decision Date | 2011-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747037548 | K112259 | 000 |