ADA News Daily

Dentsply revises guides for products

Dentsply International is rewriting the directions for use (DFU) on its Dispersalloy, Megalloy and Unison amalgam products.

Last year, in an effort to comply with labeling requirements in Germany, the company recommended not using dental amalgam for patients who are either pregnant or younger than 6 years old. Seeking to implement uniform labeling worldwide, Dentsply printed these same recommendations on its amalgam products marketed in other countries.

Since the latest scientific research continues to confirm the safety of dental amalgam, these latest DFUs have puzzled some dentists.

In a statement issued last month, the company said, >We now realize that accommodating such German requirements in universal labeling may have caused some confusion about the appropriate uses and warnings for amalgams. To address this issue, Dentsply has removed these contraindications from its website and is currently revising its DFU to reflect contraindications and warnings that are consistent with accepted scientific information. Based on current data, we continue to believe that amalgam products are safe."

The ADA's Council on Scientific Affairs recently completed a 4-year study of the scientific literature that confirms the safety of dental amalgam. The council's findings are published in the April 1998 issue of the Journal of the American Dental Association.

ADA officials note that on the basis of the scientific research and more than 150 years of experience, amalgam continues to be a safe, affordable and durable restorative material.

If you would like to share your comment or opinion about this story or any dental-related matter, please visit the ADA Publishing Co.'s Mailbag online.