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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 K260940
Device Name BellaTek Bars
Applicant
ZimVie US Corp, LLC
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact Ana Leitão
Correspondent
ZimVie US Corp, LLC
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact Ana Leitão
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/20/2026
Decision Date 09/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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