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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 K220048
Device Name NobelProcera Zirconia N1 Base
Applicant
Nobel Biocare Services Ag
Balz Zimmermann-Str. 7
Kloten,  CH 8302
Applicant Contact Bernice Jim
Correspondent
Nobel Biocare Services Ag
Balz Zimmermann-Str. 7
Kloten,  CH 8302
Correspondent Contact Bernice Jim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/06/2022
Decision Date 07/29/2022
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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