FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SleepRight Snore Aid
K Number: K250122
·
Decision May 19, 2025
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
5
Review Days
122
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Basic Information
- Device Name
- SleepRight Snore Aid
- K Number
- K250122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Splintek, Inc.
- Date Received
- January 17, 2025
- Decision Date
- May 19, 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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Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
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Other Clearances by Splintek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K212767 | SleepRight Select-Comfort Dental Guard | Dec 22, 2021 | Substantially Equivalent |
| K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard | Dec 13, 2021 | Substantially Equivalent |
| K193577 | SleepRight ProRx Custom Dental Guard | Jun 1, 2020 | Substantially Equivalent |
| K172223 | SleepRight ProRx Custom Dental Guard | Nov 17, 2017 | Substantially Equivalent |