FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NightGuard Aire Max
K Number: K252698
·
Decision Nov 3, 2025
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
1
Review Days
68
Basic Information
- Device Name
- NightGuard Aire Max
- K Number
- K252698
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nightguard Express, LLC
- Date Received
- August 27, 2025
- Decision Date
- November 3, 2025
- Product Code
- LRK
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LRK | Device, Anti-Snoring | FDA class 2 | Dental |
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