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FDA 510(k)

Brux Night Guard

K-Number: K181361 · 2019-04-11

Decision Date2019-04-11
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Brux Night Guard is a medical device manufactured by Brux Night Guard. It received FDA 510(k) clearance on 2019-04-11 under approval number K181361. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brux Night Guard?

Brux Night Guard is a medical device that received FDA 510(k) clearance on 2019-04-11. It is manufactured by Brux Night Guard. The 510(k) number is K181361.

When was Brux Night Guard approved by the FDA?

Brux Night Guard received FDA 510(k) clearance on 2019-04-11, under approval number K181361.

What company makes Brux Night Guard?

Brux Night Guard is manufactured by Brux Night Guard.

What is the FDA product code for Brux Night Guard?

The FDA product code for Brux Night Guard is MQC.

Related Clinical Trials

Related Devices (Code: MQC)

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.