Eztetic BellaTek Encode Healing Abutments
K-Number: K170013 · 2017-09-21
ApplicantBiomet 3i
Decision Date2017-09-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Eztetic BellaTek Encode Healing Abutments is a medical device manufactured by Biomet 3i. It received FDA 510(k) clearance on 2017-09-21 under approval number K170013. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Eztetic BellaTek Encode Healing Abutments?
Eztetic BellaTek Encode Healing Abutments is a medical device that received FDA 510(k) clearance on 2017-09-21. It is manufactured by Biomet 3i. The 510(k) number is K170013.
When was Eztetic BellaTek Encode Healing Abutments approved by the FDA?
Eztetic BellaTek Encode Healing Abutments received FDA 510(k) clearance on 2017-09-21, under approval number K170013.
What company makes Eztetic BellaTek Encode Healing Abutments?
Eztetic BellaTek Encode Healing Abutments is manufactured by Biomet 3i.
What is the FDA product code for Eztetic BellaTek Encode Healing Abutments?
The FDA product code for Eztetic BellaTek Encode Healing Abutments is NHA.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.