Cleared Traditional

K924974 - THE TMJ APPLIANCE
(FDA 510(k) Clearance)

K924974 · Myofunctional Research Corp. Pty. , Ltd. · Dental
Jun 1993
Decision
266d
Days
Class 1
Risk

K924974 is an FDA 510(k) clearance for the THE TMJ APPLIANCE, 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 June 23, 1993, 266 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 K924974 FDA.gov
FDA Decision Cleared SN
Date Received September 30, 1992
Decision Date June 23, 1993
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

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