This page is a mirror. URL =
|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
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
findings are published in the April 1998 issue of the Journal of the American
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
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
Copyright © 1998 American
Dental Association. Reproduction or republication is strictly prohibited without
prior written permission. All rights reserved. See
Terms & Conditions of Use for further
hier geht's weiter !
[ Das Amalgam-Zentrum ]
Copyright © 2001
Copyright © 2001
Jegliche Weiterverwendung der Texte der Amalgam-Page ist verboten.
Verlage dürfen sich wegen der Nachdruckrechte per Email an mich wenden.