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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 K202452
Device Name NobelProcera Zirconia Implant Bridge
Applicant
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg Gotlands Lan,  SE 411 17
Applicant Contact Bernice Jim
Correspondent
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg Gotlands Lan,  SE 411 17
Correspondent Contact Bernice Jim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/27/2020
Decision Date 12/03/2020
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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