Updated: Manufacturers leave the business of Dental Amalgam in Europe

Manufacturers are leaving the European business due to the new Medical Devices Regulation (MDR 2017/745) which entered into force on 26 May 2021. The legal safety requirements for dental amalgam capsules have increased significantly.

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 (ISO 10993-17:2023 Biological evaluation of medical devices Part 17: Toxicological risk assessment of medical device constituents).

The problem for manufacturers with this specification are potential compensation claims if higher releases are proven. 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.

European Manufacturers Merz, DMG Europe (both Germany), UnoDent, Prima dent (both UK), CFPM (France), Ardent (Sweden) and DMP (Greece) already left the business and Madespa (Spain) announced to leave soon.

The EU Certifications of Cavex (Netherlands), World Work Srl and BMS Dental (Italy) and Global Dental Trade (Czech Republic) expired before the deadline of 20 March 2023, which excludes any extension, and they have to completely leave the business due to the export ban by 1 January 2025 (Revised Mercury Regulation)

Nordiska Dental (Sweden) had its amalgam manufactured by Wykle Research (US), whose certificate expired in 2022, so Nordiska switched to production by Silmet (Israel). In 2023 Nordiska Dental was taken over by Dent a Pharm in Germany.

US major players Dentsply Sirona and Kerr have generally 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 and SDI announced to stop the production by 2028 at the latest.

Other EU Certificates where valid beyond March 2023 but expired by 26 May 2024 at the latest.

For further extension of the EU Certifications, two of the four remaining international manufacturers Silmet (Israel) and SDI Limited (Australia) have to proof the submission of a formal application for the conformity assessment under the MDR. The Deadline was 26 May 2024, otherwise their distribution has to stop.

Expiring MDD certifications can only be extended until 31 December 2028  acoording to the ammended MDR in March 2023 (REGULATION (EU) 2023/607))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. (a contract and the development of a technical documentation can cost more than 50,000€)

After the expirtion of old certificates in line with CE 93/42/EEC distributors may only sell-off their stocks up to the expiry date (up to 10 years).

Here is a list of Dental Amalgam Manufacturers on the European Market (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 – exit by Dec 2022)
• CFPM (France, offer removed from website in December 2022)
• DMP (Greece, CE 93/42/EEC valid until 26/05/2024 – exit by May 2024)
• Honghai (China, 👉 CE 93/42/EEC valid until 26/05/2024, products removed from the website in September 2023)
• BAMC-Medical (China, CE Conformity removed from Website in January 2023)
• World Work Srl + subcompany Bestdent (Italy 👉 CE 93/42/EEC valid until 20/9/2022)
• BMS Dental S.r.l. (Italy, 👉 CE 93/42/EEC valid until 19/02/2023)
• Madespa S.A (Spain, 👉 CE 93/42/EEC valid until 28/02/2024 offer removed from Website in November 2024)
• AT&M Biomaterial (China, 👉 CE 93/42/EEC valid until 26/05/2024 offer removed from Website in August 2024)

Manufacturer who has not yet demonstrated compliance with the requirements for extending the expired certification until 31 December 2028 :

• SDI Limited (Australia, 👉 CE 93/42/EEC valid until 26/05/2024, announced to end the production by 2028 at the latest)

Manufacturers demonstrating compliance with the requirements for extending the expired certification until 31 December 2028:

• Silmet (Israel, Co-labelled Certificates for Global Dental Trade, Safina (Czech Republic), R&S, KentDental and Septodent (France) and Nordiska (Sweden) 👉 CE 93/42/EEC valid until 31/12/2028)
• Cavex Holland BV (Netherlands, 👉 CE 93/42/EEC valid until 04/08/2022 – Announced to stop the EU distribution by 31 December 2025)
• Henry Schein + subcompanies DE Healthcare Products, Essentials Healthcare Products and CyberTech (US, 👉 CE 93/42/EEC valid until 31/12/2028 , announced to end the EU distribution by mid 2025)
• Inci Dental (Türkiye, 👉 CE 93/42/EEC valid until 31/12/2028)

International Market Overview:

Updated: Global Tracker of Amalgam Manufacturers