K252485
- 510(k) number
- K252485
- Device name
- ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
- Applicant
- 1987 Media Limited GB
- Product code
- OBR — Mouthguard, Over-The-Counter
- Decision date
- 2026-04-10
- Date received
- 2025-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252485.pdf
Official FDA record: K252485
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.