News

12.08.2021

Cobalt in dental alloys - Justification for continued use under MDR requirements

Cobalt is a component of many medical devices and is, among others, used in the Amann Girrbach portfolio in Ceramill Sintron or the CoCr casting alloys. The MDR (Medical Device Regulation), which is applicable since 2021-05-26, stipulates restrictions for the use of CMR substances (cancerogenic mutagenic reprotoxic, classification according to REACH regulation). According to Annex I No. 10.4.1 of the MDR, CMR substances of categories 1A & 1B may only be present in medical devices in a concentration exceeding 0.1% by mass if there is a specific justification for the presence of these substances.

R & D at Amann Girrbach has evaluated the latest data and summarized and explained these based on a panel of experts from the VDDI. The conclusion of this evaluation is as follows:

• the use of cobalt-based alloys has been a valuable and currently irreplaceable therapeutic agent in dentistry for over 60 years
• the results from many years of post-market surveillance demonstrate the safety and benefits of cobalt-chromium alloys in clinical use
• therapeutic alternatives exhibit certain limitations depending on the clinical indication.
• the amounts of cobalt released by these alloys are very low indeed and therefore acceptable.
• compared to daily tolerable intakes, they are harmless.

In summary it can be stated that the use of cobalt-containing alloys in the dental field can be classified as harmless according to the assessment of experts.

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