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TMJ Implants, Inc.' s Fossa-Eminence Not Approvable - FDA Dental Panel

This article was originally published in The Gray Sheet

Executive Summary

Members of FDA's Dental Products Panel questioned the adequacy of safety and efficacy data supporting use of TMJ Implants' Fossa-Eminence prosthesis for partial reconstruction of the temporomandibular joint as a first-line therapy, in recommending against FDA approval of the device Oct. 6 in Rockville, Maryland.

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