K252698
- 510(k) number
- K252698
- Device name
- NightGuard Aire Max
- Applicant
- Nightguard Express, LLC TX · US
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2025-11-03
- Date received
- 2025-08-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K252698.pdf
Official FDA record: K252698
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.