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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Abutment Design Software For Dental Laboratory
510(k) Number K181932
Device Name DTX Studio design
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 Pkwy.
Yorba Linda,,  CA  92887
Correspondent Contact Charlemagne Chua
Regulation Number872.3630
Classification Product Code
PNP  
Subsequent Product Code
NHA  
Date Received07/19/2018
Decision Date 03/01/2019
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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