Med Device Monday: Dentures!

Did you know that dentures are medical devices?

They are even among the first medical devices in history: Etruscans were already making partial dentures in the 7th century BC in northern Italy. At that time, dentures were made from human or animal teeth fastened together with gold bands. These contraptions deteriorated quickly and fit poorly, causing pain and discomfort. More critically, they could carry and pass infections from the previous owner of the teeth (!), making denture-wearers sick. However, these early dentures were easy to produce and remained popular until the 18th century. After that—through the 19th century—dentures were made of human teeth extracted from slaves, dead soldiers, or people who died from syphilis (I KNOW), or crafted in ivory from hippopotamus, elephant or walrus. This version of dentures used a base of carved ivory or golden plates, and were therefore only available to the upper classes. 

The most famous denture wearer was, of course, the first U.S. President: George Washington. Contrary to popular belief, Washington's dentures were not made of wood, but were some of the highest quality false teeth of the time. They consisted of human teeth, along with parts of horse and donkey teeth, inserted on a plate made of carved hippopotamus ivory. His historic home, Mount Vernon, discusses this and offers this photo:

Photo from mountvernon.org.

Photo from mountvernon.org.

I encourage you to go take a look at the article. While perhaps slightly horrifying to us modern-day folk, it offers keen insight into the necessity of dentures. It's not hard to see why they're classified as a medical device when you see how badly they can go wrong. 

Wooden dentures did exist during Washington's time, but were more popular in Japan, where they were invented in the early 16th century. They were either entirely made of wood or human teeth, or sculpted ivory, pagodite, or animal horn was inserted on a wooden frame meticulously carved to fit the mouth of the patient. So many options!

Real progress in this field started around 1851, with the American Goodyear brothers (yes, that Goodyear). They discovered how to make vulcanite—a flexible rubber—and invented the manufacturing process to produce hard rubber from vulcanite in 1851. The soft vulcanite was first used to make a perfect mold of the patient's mouth and then porcelain teeth were added, after which the whole enchilada was vulcanized to make the rubber hard. Vulcanite dentures were the first functional, durable, and affordable dentures, marking a great advance in dental treatment for the masses. For the first time in history, false teeth were available to the middle class—no longer a luxury only the rich could afford. 

FDA used to regulate dentures as not classified, while the preformed teeth included in the dentures were regulated as Class I or Class II devices. However, since 2015, these devices have been exempted from the premarket notification requirements. This exemption means that dental laboratories that manufacture Class II teeth don’t have to submit a premarket notification application to FDA before marketing the device in the U.S. However they are still required to register their establishment.

With the progress in dental healthcare, the development of restorative treatments, and teeth implants, the need for full dentures is not as important as a century ago, when the only way to take care of a bad tooth was to remove it. The esthetic is now as important as the functionality, and the innovations in the field constantly result in new materials and techniques, providing functional, comfortable, and esthetically-pleasing dentures to the patients.