Saremco Dental AG

Saremco Dental AG specializes in dental resin materials used for fabricating dental appliances and restorations. Their portfolio includes composite resins for crowns (like Crowntec and Saremco Print CROWNTEC), bridges (saremco print BRIDGETEC), and bonding agents (els unibond). They also produce low-shrinkage composites, such as els extra low shrinkage® composite & flow and els extra low shrinkage syringe A4, which minimize contraction during curing for better fit and longevity.

Saremco Dental AG is headquartered in Switzerland. Their devices are listed in key regulatory databases, including the EUDAMED system for EU compliance, the FDA’s 510(k) premarket notification registry, and the FDA’s Unique Device Identifier (UDI) database. These registries help track and verify their dental resin products under applicable regulations.

Saremco Dental AG’s devices fall under Class II and Class IIa classifications. In the EU, Class IIa devices are considered moderate-risk medical devices requiring conformity assessment procedures, while Class II devices may involve higher risks and stricter regulatory oversight. Similarly, the FDA categorizes these devices to ensure safety and effectiveness before market authorization.

Saremco Dental AG focuses on dental appliance fabrication materials, particularly resin-based composites and low-shrinkage resins. These materials are chosen for their durability, precision in fitting, and reduced risk of gaps or sensitivity post-procedure. Low-shrinkage composites, for example, minimize contraction during curing, which helps improve the longevity and stability of crowns, bridges, and fillings.