FDA 510(k)

kallisio stentra oral stent

K-Number: K232293 · 2023-12-22

Decision Date2023-12-22

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

kallisio stentra oral stent is a medical device manufactured by Kallisio, Inc.. It received FDA 510(k) clearance on 2023-12-22 under approval number K232293. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the kallisio stentra oral stent?

kallisio stentra oral stent is a medical device that received FDA 510(k) clearance on 2023-12-22. It is manufactured by Kallisio, Inc.. The 510(k) number is K232293.

When was kallisio stentra oral stent approved by the FDA?

kallisio stentra oral stent received FDA 510(k) clearance on 2023-12-22, under approval number K232293.

What company makes kallisio stentra oral stent?

kallisio stentra oral stent is manufactured by Kallisio, Inc..

What is the FDA product code for kallisio stentra oral stent?

The FDA product code for kallisio stentra oral stent is IYE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.