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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 K192522
Device Name TSV BellaTek Express and BellaTek Flex Abutments
Applicant
Biomet 3i, LLC
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact Krupal Patel
Correspondent
Biomet 3i, LLC
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact Krupal Patel
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/13/2019
Decision Date 12/09/2019
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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