Cleared Traditional

K143623 - Narval Brux

K143623 · Resmed Sas · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
234d
Days
-
Risk

K143623 is an FDA 510(k) clearance for the Narval Brux. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Resmed Sas (Saint-Priest Cedex, FR). The FDA issued a Cleared decision on August 13, 2015 after a review of 234 days - an extended review cycle.

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

FDA 510(k) Submission Details - K143623

510(k) Number K143623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2014
Decision Date August 13, 2015
Days to Decision 234 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 128d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Consultant

Resmed Corp
Allison C Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQC Mouthguard, Prescription

All 71
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K143623.
Ortho System
K161884 · 3Shape A/S · Apr 2017
BRX PRO Bruxism Guard
K151933 · 12th Man Technologies, Inc. · Dec 2015
SICAT OPTIMOTION
K143655 · Sicat GmbH & Co. KG · Oct 2015
M-PM-DISC
K134015 · Merz Dental GmbH · Apr 2014
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
K123161 · Smartguard, Inc. · Mar 2013
THERMOFORMED MOUTHGUARDS
K121365 · Glidewell Laboratories-Sleep Devices Group · Nov 2012