THE ORTHOTRAINER— 510(k) K924975

Substantially Equivalent

Myofunctional Research Corp. Pty. , Ltd.

FDA 510(k) clearance K924975 for THE ORTHOTRAINER, Substantially Equivalent on 1993-07-08. Applicant: Myofunctional Research Corp. Pty. , Ltd..

Clearance details

Applicant: Myofunctional Research Corp. Pty. , Ltd.
Product code: Code KMY
Advisory panel: Dental
Date received: 1992-09-30
Decision date: 1993-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helensvale, Queensland, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code KMY

product code KMY

Injury: 1,457
Total: 1,457

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.