K241729
- 510(k) number
- K241729
- Device name
- Hard Splint & Thermo-Adaptive Splint
- Applicant
- Whip Mix Corporation KY · US
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2025-03-18
- Date received
- 2024-06-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K241729.pdf
Official FDA record: K241729
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.