Is the Mini Dental Implant FDA approved? - IMTEC Corporation
Is the Mini Dental Implant FDA approved?
Yes. Prior to his preliminary discussions with Dr. Bulard, Dr. Sendax had submitted a formal application to the FDA in Washington, DC seeking permission to market the mini dental implant devices to the general public. After providing satisfactory technical and clinical evidence to that agency that the product was safe for public use and in fact had beneficial attributes, the FDA granted its formal consent to market the Mini Dental Implant device not only as a transitional or temporary dental product, but significantly, as a long-term item. ( IMTEC was the first company to receive long-term approval of its MDI implants from the FDA, and for several years, was the only compnay to have that distinction.) As stated, IMTEC's introduction of the Mini Dental Implant to the dental industry and appropriate marketing efforts under a license granted by Dr. Sendax followed the FDA's consent to market.
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