Cleared Traditional

K143623 - Narval Brux (FDA 510(k) Clearance)

K143623 · Resmed Sas · Dental device
Download Printable Device Report (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.

View all Resmed Sas devices

Submission Details

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
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 127d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 70
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