FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dormiva Anti-Snoring Mouth Guard
K Number: K261134
·
Decision May 14, 2026
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
1
Review Days
37
Basic Information
- Device Name
- Dormiva Anti-Snoring Mouth Guard
- K Number
- K261134
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Koncept Innovators, Inc.
- Date Received
- April 7, 2026
- Decision Date
- May 14, 2026
- 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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