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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 K152836
Device Name TREFOIL System
Applicant
NOBEL BIOCARE AB
BOX 5190, SE-402 26, VASTRA HAMNGATAN 1
GOTEBORG,  SE SE-411 17
Applicant Contact CHARLEMAGNE CHUA
Correspondent
NOBEL BIOCARE USA LLC
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact CHARLEMAGNE CHUA
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Codes
DZI   NHA  
Date Received09/29/2015
Decision Date 04/11/2016
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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