Mini Dental Implants are not FDA approved to use for crowns…or are they?
Where is this coming from? Why would we as dentists want to misinform the very patients that seek our help? If we don't know the answer its best to tell the patient I don't know. We should say, if you are considering getting this procedure with mini dental implants you ought to seek out a dentist that does a lot of them. I think it would be better to let our patients know the truth and let them make decisions for themselves on how they want their mouth taken care of. In the end its their health, time and money….not ours.
To answer the question do Mini Dental Implants have FDA approval to use long term for crowns or dentures… YES they are.
Image of the 510(k) approval from the FDA, straight from their website stating in plain English that mini dental implants (IMTEC MDI) are approved to use for however the dentist sees fit; long term or short term. IMTEC MDI is the substantial equivalent that most other, if not all other manufacturers have applied to get their FDA approvals.
Does being FDA approved mean anything? Well it means something, but as with any medical device you have certain risks and benefits. If we as dentists are going to try and take the position that traditional implants are FDA approved and minis are being used outside of their prescribed approval then that is just wrong and means nothing. They are both approved to use in the mouth. Do they both work…yes. Do they both have the potential to fail…yes.
They both have about the same success rate (anywhere from 96-97% success). You can make any study look good for the parameters you want it to….but in everyday wet fingered dental offices you will find this number to be correct. A skilled traditional implant dentist and a skilled mini implant dentist will have around the same success ratios. If anyone tells you they have a huge failure rate with minis then they just have not got the proper training….just like if someone tells you that traditional have a huge failure rate in their hands….you may wish to see the help of someone else.
FDA 510(k) approval for a Intra Lock Mini Dental Implant Prosthetic Abutments in plain English showing approval for use in either upper or lower jaws for a removable (denture) or fixed (crowns and/or bridge) prosthesis. You can see all the other major brands, OCO Biomedical mini and micro, ACE Surgical Secure Mini, etc… have FDA approval on the FDA website.
Paresh B Patel DDS Dentist Mooresville NC