NightGuard Aire Max
K-Number: K252698 · 2025-11-03
ApplicantNightguard Express, LLC
Decision Date2025-11-03
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
NightGuard Aire Max is a medical device manufactured by Nightguard Express, LLC. It received FDA 510(k) clearance on 2025-11-03 under approval number K252698. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NightGuard Aire Max?
NightGuard Aire Max is a medical device that received FDA 510(k) clearance on 2025-11-03. It is manufactured by Nightguard Express, LLC. The 510(k) number is K252698.
When was NightGuard Aire Max approved by the FDA?
NightGuard Aire Max received FDA 510(k) clearance on 2025-11-03, under approval number K252698.
What company makes NightGuard Aire Max?
NightGuard Aire Max is manufactured by Nightguard Express, LLC.
What is the FDA product code for NightGuard Aire Max?
The FDA product code for NightGuard Aire Max is LRK.
Related Devices (Code: LRK)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.