Eztetic BellaTek Encode Healing Abutments

Abutment, Implant, Dental, Endosseous

BIOMET 3I

The following data is part of a premarket notification filed by Biomet 3i with the FDA for Eztetic Bellatek Encode Healing Abutments.

Pre-market Notification Details

Device IDK170013
510k NumberK170013
Device Name:Eztetic BellaTek Encode Healing Abutments
ClassificationAbutment, Implant, Dental, Endosseous
Applicant BIOMET 3I 4555 RIVERSIDE DR Palm Beach Gardens,  FL  33410
ContactKrupal Patel
CorrespondentKrupal Patel
BIOMET 3I 4555 RIVERSIDE DR Palm Beach Gardens,  FL  33410
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-03
Decision Date2017-09-21
Summary:summary

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