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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 K220978
Device Name TSX Implants
Applicant
Biomet 3i, LLC
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact Mariela Cabarcas
Correspondent
Biomet 3i, LLC
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact Mariela Cabarcas
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/04/2022
Decision Date 09/14/2022
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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