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FDA 510(k)

BellaTek Encode Emergence Healing Abutments

K-Number: K212730 · 2021-12-21

ApplicantBiomet 3i, LLC
Decision Date2021-12-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BellaTek Encode Emergence Healing Abutments is a medical device manufactured by Biomet 3i, LLC. It received FDA 510(k) clearance on 2021-12-21 under approval number K212730. 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 BellaTek Encode Emergence Healing Abutments?

BellaTek Encode Emergence Healing Abutments is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Biomet 3i, LLC. The 510(k) number is K212730.

When was BellaTek Encode Emergence Healing Abutments approved by the FDA?

BellaTek Encode Emergence Healing Abutments received FDA 510(k) clearance on 2021-12-21, under approval number K212730.

What company makes BellaTek Encode Emergence Healing Abutments?

BellaTek Encode Emergence Healing Abutments is manufactured by Biomet 3i, LLC.

What is the FDA product code for BellaTek Encode Emergence Healing Abutments?

The FDA product code for BellaTek Encode Emergence Healing Abutments is NHA.

Related Clinical Trials

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Other Devices by Biomet 3i, LLC

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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.

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