K243516
- 510(k) number
- K243516
- Device name
- Remi Custom Night Guard
- Applicant
- Grindguard, Inc. CA · US
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2025-02-10
- Date received
- 2024-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243516.pdf
Official FDA record: K243516
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.