FDA Issues Final Regulation on Dental Amalgam

The U.S. Food and Drug Administration on July 28, 2009, issued a final regulation clarifying the safety of dental amalgam (silver colored fillings). They classified dental amalgam as a Class II medical device (moderate risk). This is the same classification given to porcelain, gold and dental composite (tooth colored fillings). The FDA clarified its findings as follows, "While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients.” Over the past six years, the FDA has taken many steps to assure the classification of dental amalgam is supported by strong science. In all, the agency considered some 200 scientific studies.

Bisphenol-A

Bisphenol-A (BPA) is an ingredient used in chemical compounds that line the inside of many products and serves as a major component in polycarbonate plastics. It is often found in baby bottles, sports bottles and food containers. Excessive exposure to BPA has been associated with adverse health effects such as cancer and heart disease. Once ingested, BPA may interrupt proper hormone functioning, alter genes and obstruct development. What you may ask is the dental connection?

Composite (tooth colored) fillings have been used successfully as a replacement for amalgam (silver colored) fillings since the 1960's. Composites consist of an organic resin matrix, reinforcing inorganic filler and a silane-coupling agent. Monomers used in some composite resins include Bis-phenol-A dimethacrylate (bis-DMA), ethylene glycol dimethacrylate (EGDMA) and triethylene glycol methacrylate (TEGDMA). Composites without the filler and coupling agent are used as sealants for the pits and fissures of teeth.

Composites have been improved continuously since their inception with the creation of macrofill, midfill, microfill, nanofill, mid-hybrid flowable and mini-hybrid composites. Some of these composite dental fillings release extremely small amounts of BPA during the first 24 hours post application.

Many studies have been done to determine if BPA in dental composite presents a health hazard. None of the studies has found dental composites to be a health hazard. The American Dental Association has tested the blood of dentists who had sealants on their teeth and those who did not. BPA was not found in any of the blood samples from either group. The ADA has stated that BPA in sealants and composites does not present a hazard to either dentists or patients.

In an effort to accommodate those patients who want composite fillings, but want to avoid BPA, Oakmont Dental Associates offers Venus Diamond composite restorations from the one company who has developed a BPA-free nano-hybrid composite material for anterior and posterior teeth. Venus Diamond, by Heraeus-Kulzer, is a proprietary material providing esthetics with optimum filler density, high wear resistance, color adaptation, ease of polish and an enduring shine. Please tell us if BPA is a concern to you.

The following Dental Fillings Facts have been developed by the American Dental Association to help dental consumers select the restorative materials that are best for them. For additional information, click on this link http://ada.org/public/topics/fillings.asp.

• Dental Fillings Facts - Short Version (179 KB)
• Dental Fillings Facts - Full Version (133 KB)