DENTALSUR2003 S.L.

Dentalsur2003 S.L. specializes in dental appliance fabrication materials, specifically resin-based products. Their devices include resin systems like PROCLINIC RESIN and whitening accessories for clinical use, such as kits for dental whitening procedures. These products are designed to support dental treatments, particularly those involving tooth restoration and cosmetic whitening.

Dentalsur2003 S.L. is based in Spain (ES), which means its devices are subject to European Union (EU) medical device regulations. Since their products are classified as Class I devices, they must comply with EU requirements for safety and performance, including registration in the eudamed database—a central EU repository for medical device information.

Yes, Dentalsur2003 S.L.’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This listing ensures transparency and traceability of their products under EU medical device legislation, particularly for Class I devices like their dental resins and whitening accessories.

Dentalsur2003 S.L.’s devices fall under Class I classification in the EU. This classification applies to low-risk medical devices, such as dental resins and whitening accessories, which pose minimal risk to patients. Class I devices typically require fewer regulatory controls but still must meet basic safety and performance standards before being placed on the market.