Microbrush International

Microbrush International specializes in dental applicators designed for precision application during dental hygiene and restorative procedures. Their product line includes applicators in various sizes—regular, fine, and ultrafine—such as single applicators, bulk dispenser systems, and specialized trays or sleeves. Brands like Top Dent and Scion are part of their offerings, catering to professional use with dental pastes, gels, or other oral care substances.

Microbrush International is based in the United States. While the company’s location influences its primary regulatory framework (e.g., FDA in the U.S.), its dental applicators are also registered in the EUDAMED database, demonstrating compliance with European Union medical device regulations. This registration is required for devices marketed in the EU, ensuring they meet Class I classification standards.

Microbrush International’s dental applicators are classified as Class I medical devices. This classification is based on their intended use—low-risk, non-invasive tools for applying substances in dental procedures—and aligns with regulatory frameworks like those in the EU. Class I devices typically require less stringent oversight than higher-risk categories, as they pose minimal risk to patients.

Microbrush International’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry tracks devices authorized for sale within the EU, ensuring transparency and compliance with regulatory requirements. While the company may also comply with U.S. regulations (e.g., FDA), EUDAMED registration confirms their devices meet EU-specific criteria for Class I medical devices.