K261134
- 510(k) number
- K261134
- Device name
- Dormiva Anti-Snoring Mouth Guard
- Applicant
- Koncept Innovators, Inc. SC · US
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2026-05-14
- Date received
- 2026-04-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261134.pdf
Official FDA record: K261134
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.