K232448
- 510(k) number
- K232448
- Device name
- FREEPRINT® splintmaster
- Applicant
- Detax GmbH DE
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2023-10-12
- Date received
- 2023-08-14
- 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: K232448.pdf
Official FDA record: K232448
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.