The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobel Biocare Endosseous Implants (maxillofacial Indication).
| Device ID | K090630 |
| 510k Number | K090630 |
| Device Name: | NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) |
| Classification | Prosthesis, Nose, Internal |
| 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 | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-09 |
| Decision Date | 2009-06-02 |
| Summary: | summary |