K-number	K252698
Device name	NightGuard Aire Max
Applicant	Nightguard Express, LLC
Product code	LRK
Device class	Class II
Decision date	Nov 3, 2025
Decision	Substantially Equivalent
Regulation	872.5570

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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NightGuard Aire Max

Everything you need for a 510(k) submission. Nothing you don't.