Cleared Traditional

K181361 - Brux Night Guard

K181361 · Brux Night Guard · Dental device
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Apr 2019
Decision
323d
Days
-
Risk

K181361 is an FDA 510(k) clearance for the Brux Night Guard. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Brux Night Guard (Canoga Park, US). The FDA issued a Cleared decision on April 11, 2019 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Brux Night Guard devices

FDA 510(k) Submission Details - K181361

510(k) Number K181361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2018
Decision Date April 11, 2019
Days to Decision 323 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 127d · This submission: 323d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 56
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