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

Submission Details

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.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 41
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