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 the device name listed in this FDA 510(k) record. The listed applicant is Brux Night Guard. It received FDA 510(k) clearance on 2019-04-11 under 510(k) 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. The listed applicant is Brux Night Guard. The 510(k) number is K181361.

When did Brux Night Guard receive FDA 510(k) clearance?

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

Who is the listed applicant for Brux Night Guard?

The FDA 510(k) record lists Brux Night Guard as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Brux Night Guard?

The FDA product code for Brux Night Guard is MQC.

Related Devices (Code: MQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemvia K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation K243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

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.