NightGuard Aire Max— 510(k) K252698
Substantially EquivalentNightguard Express, LLC
FDA 510(k) clearance K252698 for NightGuard Aire Max, Substantially Equivalent on 2025-11-03. Applicant: Nightguard Express, LLC.
Clearance details
- Applicant
- Nightguard Express, LLC
- Product code
- Code LRK
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lewisville, TX, US
Adverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.