Cleared Traditional

K252698 - NightGuard Aire Max

K252698 is an FDA 510(k) clearance for NightGuard Aire Max, manufactured by Nightguard Express, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K252698 · Nightguard Express, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
68d
Days
Class 2
Risk

K252698 is an FDA 510(k) clearance for the NightGuard Aire Max. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Nightguard Express, LLC (Lewisville, US). The FDA issued a Cleared decision on November 3, 2025 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nightguard Express, LLC devices

FDA 510(k) Submission Details - K252698

510(k) Number K252698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2025
Decision Date November 03, 2025
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LRK Device, Anti-snoring

All 85
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