Cleared Traditional

NightGuard Aire Max

K252698 · Nightguard Express, LLC · Dental

Nov 2025

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K252698 is an FDA 510(k) clearance for the NightGuard Aire Max, a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by Nightguard Express, LLC (Lewisville, US). The FDA issued a Cleared decision on November 3, 2025, 68 days after receiving the submission on August 27, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number	K252698 FDA.gov
FDA Decision	Cleared 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