Cleared Traditional

THE ORTHOTRAINER

K924975 · Myofunctional Research Corp. Pty. , Ltd. · Dental
Jul 1993
Decision
281d
Days
Class 1
Risk

About This 510(k) Submission

K924975 is an FDA 510(k) clearance for the THE ORTHOTRAINER, a Positioner, Tooth, Preformed (Class I — General Controls, product code KMY), submitted by Myofunctional Research Corp. Pty. , Ltd. (Helensvale, Queensland, AU). The FDA issued a Cleared decision on July 8, 1993, 281 days after receiving the submission on September 30, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.5525.

Submission Details

510(k) Number K924975 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1992
Decision Date July 08, 1993
Days to Decision 281 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KMY — Positioner, Tooth, Preformed
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5525