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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 K171466
Device Name NobelDesign, DTX Studio Design
Applicant
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg,  SE SE-411 17
Applicant Contact Charlemagne Chua
Correspondent
Nobel Biocare USA, LLC
22715 Sasvi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact Charlemagne Chua
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
NOF  
Date Received05/18/2017
Decision Date 11/29/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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