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Short statement regarding the use of Bisphenol A in dental materials

Background:

Media worldwide are consistently reporting about the noxious effects of Bisphenol A. In the past, these discussions were mainly centred on food packaging and baby products such as pacifiers and baby bottles. Recently, however, dental products such as composites and fissure sealants have become part of these discussions. Ivoclar Vivadent has taken the following position regarding the use of Bisphenol A. This statement is exclusively presented to enquiries of the media, customers and users.

Position of Ivoclar Vivadent:

  • Ivoclar Vivadent does not use Bisphenol A in its products. Furthermore, no esters from Bisphenol A, e.g. Bis-DMA, are used.
  • Independent external investigations (Geurtsen, Hamid, Joskow, Nathanson) could not detect any release of Bisphenol A in Ivoclar Vivadent products.
  • Bis-GMA and other derivatives, which are used by Ivoclar Vivadent, cannot release any Bisphenol A when used in oral conditions. Ivoclar Vivadent performs random trace analyses of its raw materials in order to ensure that these materials are free of Bisphenol A.

According to the current standard of knowledge, the products of Ivoclar Vivadent pose no risk of releasing Bisphenol A and represent thus no additional risk to the user and patient.

Facts:

  • Bisphenol A has a hormone-like effect. It is quickly degraded in the body. Any noxious effects on the human body have not yet been proven.
  • After animal testing in mice, the European Food Safety Authority has set the tolerable daily intake (TDI value) of Bisphenol A to 50 μg/kg body weight. Biomonitoring studies have shown that the exposure of the general population to Bisphenol A is 10 μg/kg body weight on average and thus significantly below the threshold level.
  • The most frequent source of exposure to Bisphenol A for humans is food packaging containing polycarbonate and thermal paper.
  • Investigations of different dental fissure sealants have found an increased level of Bisphenol A release in competitor products. The main source of Bisphenol A, which is released from dental sealants and composites, is attributed to hydrolysis and/or enzymatic decomposition of Bis-DMA. However, Bis-DMA is only used by certain dental manufacturers.

Last update: 11 November 2013