FDA Approval Information

TMJ Concepts (located in Ventura, CA) began manufacturing these implants under an FDA premarket notification [510(k)] clearance in December 1997. Prior to this time, these implants were manufactured by Techmedica, Inc. (now closed, which had been located in Camarillo, CA) from January 1989 to September 1993.

TMJ Concepts submitted a premarket approval [PMA] application on January 6, 1999, in response to the publication of the final rule in the Federal Register of December 30, 1998, requiring submission of PMA applications for total temporomandibular joint protheses in accordance with section 515(b) of the Food Drug and Cosmetic Act. This PMA received FDA approval on July 2, 1999, allowing TMJ Concepts to continue providing these implants for TMJ patients.

For more detailed information, please view the FDA’s web site for Premarket Approval P980052.