Clearance Summary
THE ORTHOTRAINER received FDA 510(k) clearance under submission number K924975, sponsored by Myofunctional Research Corp. Pty. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-07-08.
- Submission: K924975
- Applicant / Sponsor: Myofunctional Research Corp. Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5525
- Decision date: 1993-07-08
Classification & Regulation
This clearance is catalogued under FDA product code KMY and 21 CFR 872.5525, within the Dental review panel as a Class I device.