TSV BellaTek Encode Healing Abutments
K-Number: K173374 · 2017-12-13
ApplicantBiomet 3i
Decision Date2017-12-13
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TSV BellaTek Encode Healing Abutments is a medical device manufactured by Biomet 3i. It received FDA 510(k) clearance on 2017-12-13 under approval number K173374. 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 TSV BellaTek Encode Healing Abutments?
TSV BellaTek Encode Healing Abutments is a medical device that received FDA 510(k) clearance on 2017-12-13. It is manufactured by Biomet 3i. The 510(k) number is K173374.
When was TSV BellaTek Encode Healing Abutments approved by the FDA?
TSV BellaTek Encode Healing Abutments received FDA 510(k) clearance on 2017-12-13, under approval number K173374.
What company makes TSV BellaTek Encode Healing Abutments?
TSV BellaTek Encode Healing Abutments is manufactured by Biomet 3i.
What is the FDA product code for TSV BellaTek Encode Healing Abutments?
The FDA product code for TSV BellaTek Encode Healing Abutments is NHA.
Related Clinical Trials
Other Devices by Biomet 3i
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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.