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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 K252197
Device Name Nobel Biocare S Series Implants
Applicant
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg,  SE SE 411 17
Applicant Contact Bernice Jim
Correspondent
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg,  SE SE 411 17
Correspondent Contact Bernice Jim
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/14/2025
Decision Date 02/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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