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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K132746
Device Name NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
Applicant
NOBEL BIOCARE USA, LLC
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Applicant Contact PHUONG NGUYEN
Correspondent
NOBEL BIOCARE USA, LLC
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Correspondent Contact PHUONG NGUYEN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/03/2013
Decision Date 01/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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