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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 K212125
Device Name Nobel Biocare Dental Implant Systems Portfolio - MR Conditional
Applicant
Nobel Biocare AG
P.O. Box, 8058 Zurich-Airport
Balsberg, Balz Zimmermann-Str. 7,  CH 8302
Applicant Contact Bernice Jim
Correspondent
Nobel Biocare AG
P.O. Box, 8058 Zurich-Airport
Balsberg, Balz Zimmermann-Str. 7,  CH 8302
Correspondent Contact Bernice Jim
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/07/2021
Decision Date 09/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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