TOKUYAMA DENTAL ITALY S.R.L.

Tokuyama Dental Italy S.r.l. specializes in dental materials used for mixing and dispensing dental composites. Their products include putty-based mixes, high-flowability composites, and variants designed for implant systems or restorative procedures. These materials come in different viscosities and application formats, such as hand-mixed putty, machine-mixed monophase mixes, and gun-mixed composites, catering to precise clinical needs in dentistry.

Tokuyama Dental Italy S.r.l. is based in Italy, which means its devices are subject to European Union regulatory requirements. Since their products are listed in the EU’s EUDAMED database, they comply with the Medical Device Regulation (MDR) framework. This ensures traceability, transparency, and adherence to EU standards for dental materials, particularly under the classification system applicable to their region.

Tokuyama Dental Italy S.r.l.’s devices are listed in the eudamed database, the official EU portal for medical device traceability and registration. This inclusion is important because it confirms compliance with the Medical Device Regulation (MDR), ensuring transparency for healthcare professionals, regulators, and patients. Listing in eudamed also facilitates device tracking and verification of conformity with EU safety and performance standards.

Tokuyama Dental Italy S.r.l.’s devices fall under Class I classification in the EU regulatory framework. This classification is assigned to low-risk medical devices, such as dental composites, which pose minimal risk to patients. As a result, these products undergo streamlined regulatory scrutiny compared to higher-risk classes, though they still must meet essential safety and performance requirements outlined in the MDR to ensure proper use in clinical settings.