SAREMCO Dental AG, an independent Swiss company in the dental industry, is one of the first companies in the world to receive certification of a light-curing dental filling material - saremco els composite - according to the new Medical Device Regulation (MDR, EU 2017/745). This certification is further proof of SAREMCO Dental's leading position in the field of light-curing dental materials.

The MDR contains a number of new, unprecedented requirements to ensure the safety and quality of medical devices. The MDR certification of a dental filling resin means that the product has undergone extensive testing and quality controls. This includes evaluating the biocompatibility of the material, ensuring the safety of the manufacturing process and confirming the reliable function of the material under various conditions. By choosing an MDR-certified filling material, patients and dentists can be sure that the product meets the latest and most stringent safety requirements, which significantly reduces the risk of complications and offers long-term health benefits.

saremco els composite has been in use worldwide for over 20 years and has proven itself through its clinical safety and reliability. It is characterized by a HEMA and TEGDMA-free composition that can reduce the allergy potential, as well as an extremely low shrinkage stress that minimizes the risk of marginal gaps. With a wide, vibrant and stable color palette including four unique bleach colors and very low water absorption, the product offers optimal properties.

In addition to the MDR certification of the quality management system, SAREMCO Dental AG successfully passed the Medical Device Single Audit Program (MDSAP) for the USA, Canada and Australia at the end of 2023. This confirms compliance with the regulatory requirements for these countries. These successes underline SAREMCO Dental's commitment to meeting the highest quality and safety standards and to being optimally positioned for future challenges.

"SAREMCO Dental has stood for the highest quality and innovative strength in the field of dental materials since its founding," says Sven Hauser, CEO of Saremco Dental AG. "The certifications achieved confirm our continuous pursuit of excellence and give our customers the security of using products that are both clinically proven and fully comply with the latest regulatory requirements."

SAREMCO Dental AG is a renowned medical technology company based in Rebstein, Switzerland. For over 35 years, the company has been developing and producing high-quality dental products that are used in dental practices and dental laboratories around the world. With a clear focus on quality and safety, SAREMCO Dental continuously contributes to the further development of dentistry and creates a supportive environment for personal growth and professional development.