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 |