K253641
- 510(k) number
- K253641
- Device name
- Owl Night Guard
- Applicant
- Owl Dental Lab, Inc. CA · US
- Product code
- OBR — Mouthguard, Over-The-Counter
- Decision date
- 2026-02-26
- Date received
- 2025-11-19
- 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: K253641.pdf
Official FDA record: K253641
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.