If you're considering dental crowns for health and/or appearance reasons, you likely have a few questions about the safety and potential hazards of the procedure. The FDA oversees all dental products and crowns are no exception.

FDA Classification

Because there is no singular maker and design of dental crowns, there is no one FDA case of approval to examine. Crude crowns have even been around for thousands of years. Advances that led to the construction of crowns as they are today occurred in the late 19th and early 20th century. FDA approval followed thereafter.
Crowns are classified as Class I medical devices, which is a positive sign for the consumer. Class I medical devices are generally found to be safe enough to require only general controls and oversight from the FDA following registration from the manufacturer.

Crown Lead Scare

In 2008, the FDA addressed concerns about the level of lead present in some dental crowns. Trace amounts of lead were found in some metal crowns, but the FDA did further testing and found that there was not enough to cause potential harm. Lead is not present at all in some crowns, like those made entirely of porcelain.
Dental crowns are age-old dental devices that have been approved by the FDA for decades, so patients should be confident in their safety.