The following data is part of a premarket notification filed by Nobel Biocare Usa, Llc with the FDA for Nobelprocera Angulated Screw Channel Abutment Conical Connection.
Device ID | K132746 |
510k Number | K132746 |
Device Name: | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | NOBEL BIOCARE USA, LLC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
Contact | Phuong Nguyen |
Correspondent | Phuong Nguyen NOBEL BIOCARE USA, LLC 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 | 2013-09-03 |
Decision Date | 2014-01-30 |