Since the new Medical Devices Regulation (MDR 2017/745) enterd into force on May 26, 2021, the legal safety requirements for dental amalgam capsules have increased significantly, why manufacturers start leaving the business.
Of the 23 European dental amalgam manufacturers listed in the EU’s 2020 Assessment, only 3 minor manufacturers remain that have not yet declared their exit from the business.
Among others Kerr and DMG have recently left the business; Ivoclar, DMP, Ardent and UnoDent (which is no longer an EU Producer) have confirmed that they will leave in the near future. Nordiska has moved its production to the US and the amalgam branch of Safina, has been taken over by Silmet in Israel.
Only Cavex, Madespa, World Work Srl, and Global Dental Trade (which was not listed in the EU’s 2020 report) have not yet declared their exit, but their certifications according to 93/42/EEC will expire soon.
For certifications under the MDR, manufacturers have to proof that the release of mercury and other components of amalgam (in mass/unit time) do not exceed the safety thresholds under all possible conditions like, teeth grinding, chewing, age corrosion or oral galvanism. These are requirements that amalgam fillings didn’t have to fulfill before.
How can the EU hold on to amalgam fillings when there are strong indications that they may no longer be available on the European market by 2025?
The transition period during which certificates under the former Medical Devices Directive (MDD 93/42/EEC) are still valid will end on May 26, 2024 at the latest and certifications according to MDR 2017/745 have not been issued so far.
The major international producer Dentsply Sirona has stopped its production of dental amalgam in 2020 and only stocks from the dental depots can still be sold until 2024 in Europe.
Here is a list of key players in the European market (including manufacturer from outside the EU) with the expiration dates of their certificates for dental amalgam and decisions to leave the business.
Merz Dental(Germany, Exit by Dec 2019) Dentsply Sirona(US, CE 93/42/EEC valid until 26/05/2024, Exit by Dec 2020) DMG(Germany/US, Exit by 2021) Envista Holdings(Kerr, US/Italy, Exit by Jan 2022) Uno Dent(UK, Exit by June 2022) Prima Dent(UK, Subsidiary: SSWhite, Exit before July 2022) AB Ardent(Sweden, 👉 CE 93/42/EEC valid until 01/09/2022 – announced exit by Sep 2022) Ivoclar Vivadent(Lichtenstein, CE 93/42/EEC valid until 26/05/2024 – announced exit by Dec 2022) DMP(Greece, CE 93/42/EEC valid until 26/05/2024 – announced exit by 2024)
- Cavex Holland BV (Netherlands, 👉 CE 93/42/EEC valid until 04/08/2022 – Exit in Germany by Jan 2022)
- World Work Srl (Italy, 👉 CE 93/42/EEC valid until 20/9/2022)
- Wykle Research (US, Amalgam segment of Nordiska Dental (Sweden), 👉 CE 93/42/EEC valid until 30/09/2022)
- Global Dental Trade (Czech Republic, 👉 CE 93/42/EEC valid until 18/12/2022)
- Madespa S.A (Spain, 👉 CE 93/42/EEC valid until 19/02/2023)
- BSM Dental S.r.l. (Italy, 👉 CE 93/42/EEC valid until 19/02/2023)
- Silmet (Israel, Amalgam segment of Safina (Czech Republic), R&S (France), KentDental (France), Septodent (France) 👉 CE 93/42/EEC valid until 06/03/2024)
- Henry Schein + subcompanies (US, 👉 CE 93/42/EEC valid until 02/02/2024)
- SDI Limited (Australia, CE 93/42/EEC valid until 26/05/2024)
- AT&M Biomaterial (China, CE 93/42/EEC valid until 26/05/2024)
- CFPM (France, CE 93/42/EEC valid until ?)
- Honghai (China, CE 93/42/EEC valid until ?)
- BAMC-Medical (China, CE 93/42/EEC valid until ?)
Further Players in the Non-EU market are coming especially from China, India, Mexico, Turkey and the US.