The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelprocera Ti Abutment Camlog Platforms.
Device ID | K122602 |
510k Number | K122602 |
Device Name: | NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS |
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 | 2012-08-27 |
Decision Date | 2013-03-13 |
Summary: | summary |