Is the Mini Dental Implant FDA approved?

Answer 1

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 company 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.

Answer 2

Yes, it is approved. The approval relates to the fact that it is a similar device to others on the market, and dates back to 1976. The FDA does not necessarily need new data to support each application of a "new" variation of a device that has already been approved.
My own opinion (having attended a seminar) is that it is a very useful device for the original intent of temporary stabilisation of overdentures, and later this became acceptable for permanent stabilisation of overdentures.
The way I've read the FDA material and guidelines, they only approve it insofar as the implant is concerned, not necessarily what else the manufacturers or dentists would like to connect to it on top.
I'm not convinced that it should be used for supporting crown and bridgework as currently promoted, particularly the F.I.R.S.T. system. On an open forum like this, I am wary of expanding on my reasons.
As a matter of normal procedure, I'd suggest you get 2nd opinions from specialists if this is the type of use you're considering.