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FDA 510(k)

OpenSensorX Series

K-Number: K220556 · 2022-04-13

ApplicantDentimax, Inc.
Decision Date2022-04-13
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OpenSensorX Series is a medical device manufactured by Dentimax, Inc.. It received FDA 510(k) clearance on 2022-04-13 under approval number K220556. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OpenSensorX Series?

OpenSensorX Series is a medical device that received FDA 510(k) clearance on 2022-04-13. It is manufactured by Dentimax, Inc.. The 510(k) number is K220556.

When was OpenSensorX Series approved by the FDA?

OpenSensorX Series received FDA 510(k) clearance on 2022-04-13, under approval number K220556.

What company makes OpenSensorX Series?

OpenSensorX Series is manufactured by Dentimax, Inc..

What is the FDA product code for OpenSensorX Series?

The FDA product code for OpenSensorX Series is MUH.

Other Devices by Dentimax, Inc.

K251206Digital X-Ray DentiMax Pro Imaging System

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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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