FDA · official record K924974Substantially Equivalent for Some Indications

THE TMJ APPLIANCE

Name: THE TMJ APPLIANCE — FDA K924974
Creator: Myofunctional Research Corp. Pty. , Ltd.
Keywords: THE TMJ APPLIANCE, THE TMJ APPLIANCE, K924974, KMY, FDA

United StatesKMYMyofunctional Research Corp. Pty. , Ltd.

Verified

Official record identity

FDA application number: K924974
Decision date: June 23, 1993
Published decision: Substantially Equivalent for Some Indications

Classification

Product code: KMY

Published parties

Applicant: Myofunctional Research Corp. Pty. , Ltd.

Additional source fields

Decision code: SN
Published decision: Substantially Equivalent for Some Indications
Submission type: Traditional
Received date: 1992-09-30
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.5525

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.