The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelclinician.
| Device ID | K123976 |
| 510k Number | K123976 |
| Device Name: | NOBELCLINICIAN |
| Classification | System, Image Processing, Radiological |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Phuong Nguyen |
| Correspondent | Phuong Nguyen NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-03-26 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NOBELCLINICIAN 79108119 4405078 Live/Registered |
Nobel Biocare Services AG 2011-12-14 |