K250743
- 510(k) number
- K250743
- Device name
- Remvia NightGuard
- Applicant
- Remvia MO · US
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2025-12-05
- Date received
- 2025-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250743.pdf
Official FDA record: K250743
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.