During the gold rush, hundreds of thousands flocked to the gold-rich hills of California in search of something miraculous that could change their lives dramatically. Instead, many gold hopefuls found a metal called pyrite, also referred to as “fool’s gold,” that has little to no value.
There are parallels between today’s dental professionals on the cutting edge of periodontal treatment and the so-called 49ers who came searching for gold. In the search for a laser treatment that effectively treats the complexities of periodontitis, dentists and periodontists have a plethora of laser companies to choose from, many of which have Food and Drug Administration (FDA) clearances. Only one treatment, though, has proof that it can achieve True Periodontal Regeneration — the regrowth of bone and tissue lost to gum disease. That treatment is the LANAP protocol.
Per the FDA, A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements. Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.
What’s a “new indication of use” clearance?
To understand the difference between the two types of FDA clearances for indication, you have to back up to the original Millennium Dental Technologies (MDT) claim for new indication of use. True Regeneration™ with the LANAP® protocol is a new clinical indication, requiring scientific evidence for clearance; approval is based on a determination by FDA that the application contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for the new indication of use. The MDT application for True Regeneration was 593 pages containing new, unpublished human histology results. This application was subjected to intense scrutiny by the FDA, including analysis of the paperwork, confirmation that the PerioLase MVP-7 operates correctly, and efficacy of the claims per the scientific evidence. Based on the rigorous scientific evidence, the new clinical indication for the LANAP protocol was given an FDA clearance in March 2016
What’s a “me too” clearance?
Recently, other laser companies have received “me too” FDA clearances, which is also referred to as an FDA clearance for an existing indication for use. Clearance is based on determination that the device is substantially equivalent to a legally marketed predicate device. Clinical evidence is not required for such a clearance. The bottom line is the FDA does not require the same standard of proof that a “me too” device can achieve the same results, only that it is also another dental laser that claims to do the same thing. Other companies with True Regeneration clearances do not have the scientific evidence to prove regeneration has occurred.
So what does it all mean?
The importance of MDT’s FDA clearance for True Regeneration is that it contains the phrase “with the LANAP protocol,”
meaning that only the LANAP protocol can achieve the results advertised of new cementum, new periodontal ligament and new alveolar bone. This is the key part of why MDT requires intensive hands-on training with live patients before it will even ship a laser — to protect both the clinician and their patients. Clinicians who attempt to perform the LANAP protocol without proper training have been fined for not practicing to the LANAP standard of care.
If you had the choice between actual gold and pyrite, which would you choose? The decision is a no-brainer. It’s the same when it comes to picking the PerioLase MVP-7 and LANAP protocol over other options that claim to do the same. Not only will the LANAP protocol give your patients priceless results, you’re also likely to dramatically increase your practice revenue in the process. Most LANAP trained clinicians report upwards of $100,000 in profits in the first year alone. Don’t be fooled — True Regeneration with the LANAP protocol is the only 24k gold standard of laser periodontitis treatment.
• The LANAP protocol’s FDA clearance for True Regeneration was based on nearly 600 pages of scientific evidence that was scrutinized thoroughly.
• After MDT received the clearance in 2016, several other laser companies received “me too” clearances, which are not subjected to the same scrutiny and clinical evidence.
• Critically, the True Regeneration clearance contains the phrase “with the LANAP protocol” — meaning no other laser treatment protocol can achieve the same results of bone and tissue regrowth.
• Other lasers claim they can do this, but can’t — the lack of research speaks for itself.]]>