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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 K173374
Device Name TSV BellaTek Encode Healing Abutments
Applicant
Biomet 3i
4555 Riverside Drive
palm beach gardens,  FL  33410
Applicant Contact nichole o’neil
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact linda k. schulz
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/27/2017
Decision Date 12/13/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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