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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K142260
Device Name NobelActive
Applicant
NOBEL BIOCARE AB
VASTRA HAMNGATAN 1
GOTEBORG,  SE SE-411 17
Applicant Contact PHUONG NGUYEN SON
Correspondent
NOBEL BIOCARE USA, LLC
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact Ji Eun Hwang
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/14/2014
Decision Date 05/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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