Most of the dental implants used in the US (and virtually all the ones we use at Beyond Exceptional Dentistry) are what we call root-form dental implants, but another type of dental implant, called blade form, has recently shown such impressive results that the US Food and Drug Administration (FDA) has advised reclassifying them, making them more available to the public.
What Are Blade Form Dental Implants?
A root form dental implant is structured like a screw. It has a rounded stem that fits into the jawbone, where it is incorporated into the bone. Blade form implants have wide, flat (blade shaped) stems that are inserted into the bone. Some people may have jaw anatomy that’s better suited to a blade form than a root form dental implant.
How Blade Form Dental Implants Won Their New Status Recommendation
Blade form dental implants are currently classified as Class III, a designation intended for high-risk devices that must be tightly regulated. That’s because there was too little known about the devices to allow them to enter the market without special oversight.
Now, though, a July 18th regulatory review panel looked at the evidence available, and determined that blade form dental implants should be regulated as Class II medical devices, which means that they won’t necessarily need premarket approval before new models are marketed and sold.
Chief among the factors considered by the FDA advisory committee were measures of safety and effectiveness. The new data addressed all the previous concerns that had gotten blade form implants classified as Class III, and it showed very good results in terms of survival. Most studies showed 90% or better survival rate at 5 years, with 100% survival reported in many cases.
How the Reclassification Affects You
Technically, the reclassification of blade form implants won’t affect you directly. After all, the classification system refers to what manufacturers have to do before marketing a device in the US. However, there may be a significant indirect effect.
When dentists see the new classification, it changes the way they think about the blade form dental implants. Class III is “high risk” and Class II is “medium risk,” which can make a big difference to dentists.
And based on the impressive results shown in the studies reviewed, it’s likely a lot of us will be looking more closely at blade form dental implants, which may help you get better results.
Currently we believe that, although they have received improved classification, blade form implants will need a longer track record before they meet our standards for giving patients the highest degree of success.
To talk about your dental implant options in Savannah, Georgia, please call (912) 234-8282 today.