K230548
- 510(k) number
- K230548
- Device name
- Myoaligner Appliance
- Applicant
- Myohealth Technologies, LLC OR · US
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2024-02-02
- Date received
- 2023-02-28
- 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: K230548.pdf
Official FDA record: K230548
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.