Immunology Devices Panel Meeting
The FDA hosted a public meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee in November 2019 to discuss metal-containing implants and dental amalgam.
Dental amalgam is a dental filling material which is used to fill cavities caused by tooth decay. Its primary component is elemental mercury.
Tooth decay results in a loss of tooth structure. Dental amalgam is one type of dental filling material used to repair tooth structure that has been destroyed by decay and to restore the biting surfaces of a decayed tooth. Other materials, commonly referred to as composites, are also used for dental fillings.
This website contains information about dental amalgam and other types of dental filling materials. It provides general information and is not meant to replace a discussion with your dentist.
The following links provide additional information related to the FDA's regulation of dental amalgam.
- Summary of Changes to the Classification of Dental Amalgam (Appendix I)
- Final Rule for Dental Amalgam (PDF - 444k) (Appendix II)
- Special Controls Guidance Document (Appendix III)
- White Paper and Addendum (PDF - 559k) (Appendices IV and V)
The following links provide additional information about the FDA’s role in regulating medical devices.
The following links provide additional information about sources of mercury exposure and bioaccumulation:
The following link provides additional information about allergy or sensitivity to mercury:
FDA does not regulate the disposal of dental amalgam. The disposal of dental amalgam is regulated by the Environmental Protection Agency (EPA) and state and local authorities. See the following link for EPA guidelines: http://www.epa.gov/waterscience/guide/dental/