Why medical grade silicone is mandatory in dentistry

Are you aware of what you are putting in your orthodontic patients’ mouths?

Medical grade silicones are silicones tested for biocompatibility and are appropriate to be used for dental and medical applications.

The  Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates devices implanted into the body and specifically  regulates  dental materials.

The FDA regulate silicones used in food contact under the auspices of the Center for Food Safety and Nutrition (CFSAN) and for use in pharmaceuticals under the auspices of the Center for Drug Evaluation and Research (CDER).

Medical grade silicones are generally grouped into three categories: non implantable, short term implantable, and long-term implantable. Materials approved as Class V and VI are considered medical grade.  Silicones used in the dental environment should be  at least Class VI certified.

Don’t take the risk of using food grade silicone products in your patients’ mouths. Regulators establish guidelines based on rigid biocompatibility testing. Always check the Material Safety Data Sheet in every product or device you prescribe to avoid issues.