Sigma Dental Systems - Emasdi GmbH

Sigma Dental Systems - Emasdi GmbH specializes in intraoral scanners, such as the UltraSmart Plusn Study, UltraSmart plus Cube touch, and UltraSmart zwei. These devices are designed to capture highly detailed digital impressions of a patient’s dental structures, which are essential for creating precise restorations, crowns, bridges, and other dental prosthetics. They streamline workflows by replacing traditional physical impressions with digital alternatives.

The company is headquartered in Germany, which aligns with its focus on providing high-quality dental technology solutions tailored for European dental practices and laboratories. The German location also reflects its adherence to stringent European medical device regulations.

Sigma Dental Systems - Emasdi GmbH’s intraoral scanners are listed in the eudamed database, which is the official EU registry for medical devices. This registration ensures transparency and compliance with EU requirements for Class I devices, allowing dental professionals and regulatory authorities to verify the manufacturer’s details and device information.

The company’s intraoral scanners fall under EU Class I medical device classification. This classification is determined by their intended use—capturing digital impressions for diagnostic and restorative purposes—and their low-risk profile, as they do not involve invasive procedures or significant health risks. Class I devices typically require conformity assessment procedures like self-certification or EU-type examination, depending on specific features.