Since the new Medical Devices Regulation (MDR 2017/745) entered into force on May 26, 2021, the legal safety requirements for dental amalgam capsules have increased significantly, why manufacturers start leaving the European business.
Merz, DMG Europe (both Germany), UnoDent, Prima dent (both UK), CFPM (France), and Ardent (Sweden) left the market and DMP (Greece) announced to leave soon.
US major players Dentsply Sirona and Kerr have left the business, due to the MDR and the 👉 FDA’s safety warning for the use of dental amalgam in 2020. Ivoclar from Liechtenstein left the European sales in a first step.
The EU Certifications of Cavex (Netherlands), World Work Srl and BMS Dental (Italy), Wykle Research (US, the Amalgam segment of Nordiska Dental in Sweden), Global Dental Trade (Czech Republic) and BAMC-Medical (China) have expired to distribute their amalgam in the EU.
Some might continue to export dental amalgam to third countries, but only few would try to aplly for a new MDR approval.
How can the EU hold on to dental amalgam when there are strong indications that it may no longer be available on the European market by 2028?
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.
Dental amalgam didn’t have to fulfill these requirements before. Consequently certifications according to MDR 2017/745 haven’t been issued so far and are unlikely to be issued.
The transition period of the MDR should have ended on 26 May 2024 but was extended on 20 March 2023 with Regulation EU 2023/607 until 31 December 2028 for Class IIa devices like restorative filling materials under following conditions:
- The product continues to comply with the MDD/AIMDD;
- the device has not undergone any significant change in design or purpose;
- the device does not pose an unacceptable risk to the health and safety of patients and users;
- the manufacturer has established a quality management system in accordance with Article 10(9) MDR by 26 May 2024; and
- the manufacturer has submitted a formal application for conformity assessment under the MDR by 26 May 2024 and has signed a written agreement with a notified body for conformity assessment under the MDR by 26 September 2024.
Manufacturers whose certificates have expired before 20 March 2023 must proof having signed a written agreement with a notified body before the expiry date (a contract can cost more than 50,000€) or having obtained an exemption for another year from national authorities (which are very difficult to obtain).
After the expirtion of old certificates in line with CE 93/42/EEC only distributors are allowed to continue selling the devices out of stocks until the expiration date (about three years).
Here is a list of manufacturers offering Dental Amalgam in Europe (including manufacturer from outside the EU) with the end dates of their certificates and decisions to generally 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 Europe(Germany/US, CE 93/42/EEC valid until 26/05/2024, 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 (Subcompany Orbis) 👉 CE 93/42/EEC valid until 01/09/2022 – exit by June 2022) Ivoclar Vivadent(Liechtenstein, CE 93/42/EEC valid until 26/05/2024 – announced exit by Dec 2022) CFPM(France, offer removed from website in December 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 until04/08/2022 – Exit in Germany by Jan 2022)
- World Work Srl + subcompany Bestdent (Italy 👉
CE 93/42/EEC valid until20/9/2022)
- Wykle Research (US, Amalgam segment of Nordiska Dental (Sweden), 👉
CE 93/42/EEC valid until30/09/2022)
- Global Dental Trade (Czech Republic, 👉
CE 93/42/EEC valid until18/12/2022)
- BAMC-Medical (China, CE Conformity removed from Website in January 2023)
- BMS Dental S.r.l. (Italy, 👉
CE 93/42/EEC valid until19/02/2023)
- Henry Schein + subcompanies DE Healthcare Products and CyberTech (US, 👉 CE 93/42/EEC valid until 02/02/2024, CE might be extended to 31/12/2028)
- Madespa S.A (Spain, 👉 CE 93/42/EEC valid until 28/02/2024, received an exemption for another year from national authorities acoording to Article 97(1), CE might be extended to 31/12/2028)
- Silmet (Israel, Amalgam segment of Safina (Czech Republic), R&S (France), KentDental (France), Septodent (France) 👉 CE 93/42/EEC valid until 06/03/2024 , CE might be extended to 31/12/2028)
- SDI Limited (Australia, 👉 CE 93/42/EEC valid until 26/05/2024, CE might be extended to 31/12/2028)
- AT&M Biomaterial (China, 👉 CE 93/42/EEC valid until 26/05/2024, CE might be extended to 31/12/2028)
- Honghai (China, 👉 CE 93/42/EEC valid until 26/05/2024, CE might be extended to 31/12/2028)
- Inci Dental (Türkiye, 👉 CE 93/42/EEC valid until 26/05/2024, CE might be extended to 31/12/2028)
Further Players in the Non-EU market are coming especially from the US, India, Mexico, and China. But China is restricting the construction, renovation, and expansion of dental amalgam material production devices since 2019.