If you are considering procedures to repair receding gums, you might have seen the exciting new announcement that the FDA has, for the first time, cleared technology that allows for True Regeneration™ of periodontal tissue. New bone, new cementum, and even new periodontal ligaments can all now be regenerated using this one-of-a-kind technology.

Or maybe not. Actually, we’re not saying that the laser doesn’t result in any of these things it promises, only that a) it might not, and b) at any rate, it’s not revolutionary.

Why the Device Was “Cleared,” Not “Approved” by the FDA

If you pay attention to medical technology, you are probably aware that there’s a world of difference between devices that are “cleared” by the FDA versus those that are “approved.” Unfortunately, most consumers don’t understand this crucial difference.

FDA approval means that a device has been given a rigorous premarket evaluation by the FDA. It’s been subjected to clinical trials designed to show that the device is both safe and effective for its stated applications. This process takes years and can be expensive, but for a truly revolutionary device or drug, it’s worth it–the technology is new and the rewards will be commensurately high.

But FDA clearance is done using a shortcut process. This process, known as 510(k) premarket clearance allows devices to be marketed that haven’t been subjected to rigorous testing, per se. Instead, the devices can be marketed because they are “substantially equivalent” to other devices that are already being marketed.

In other words, any device that goes through the 510(k) process has been cleared specifically because it’s not original or revolutionary. It’s basically the same old boring device, maybe slightly repackaged and with a few new bells and whistles.

So, what about the claims being made by the manufacturer in this case? It’s worth noting that there is no mention of these claims in the 510(k) clearance notice. And there’s nothing about it in the FDA registration about the indications it’s cleared for, other than it’s a surgical laser intended to “destroy” tissue.

So, what do we do with these claims? At best, we can say that there are many lasers used for periodontal treatment that might do this. At worst, we should note that the American Dental Association (ADA) specifically refers to limitations of the 510(k) process in relation to dental lasers:

the Council feels that the 510(k) process alone is not inherently sufficient to scientifically demonstrate safety, efficacy, or effectiveness for marketed dental laser applications in all cases. Properly designed preclinical and clinical studies are often needed to demonstrate safety, efficacy and clinical effectiveness for specific products and uses.

In other words, caveat emptor (buyer beware) as always.

Gum Grafts Can Set the Stage for Regeneration

The claims of tissue regeneration state that they occur under the gums. But what if receding gums mean you have no gums to establish a site for healing? In that case, you may need a gum graft to cover your roots and bones so they can heal.

To learn about your receding gums treatment options in Orange County, please call (949) 551-5902 for an appointment at Rice Dentistry in Irvine.