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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 K170013
Device Name Eztetic BellaTek Encode Healing Abutments
Applicant
BIOMET 3I
4555 RIVERSIDE DR
PALM BEACH GARDENS,  FL  33410
Applicant Contact KRUPAL PATEL
Correspondent
BIOMET 3I
4555 RIVERSIDE DR
PALM BEACH GARDENS,  FL  33410
Correspondent Contact KRUPAL PATEL
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/03/2017
Decision Date 09/21/2017
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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