K251778
- 510(k) number
- K251778
- Device name
- Remi Custom Night Guard
- Applicant
- Remi CA · US
- Product code
- OBR — Mouthguard, Over-The-Counter
- Decision date
- 2025-10-17
- Date received
- 2025-06-10
- 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: K251778.pdf
Official FDA record: K251778
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.