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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 K241032
Device Name BellaTek Bars
Applicant
Biomet 3i, LLC
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact Krupal Patel
Correspondent
Michael Davis Quality and Regulatory Consulting, LLC
204 Norwick Forest Dr.
Alabaster,  AL  35007
Correspondent Contact Michael Davis
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/16/2024
Decision Date 07/15/2024
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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