Dentalia Dentálgyártmány Kft.

Dentalia Dentálgyártmány Kft. specializes in dental protective devices, including custom dental molds (referred to as *fejtámlavédő*) and dental impression materials. Their product line includes kits like Simplex, Simplex-Plus, and Simplex-Plus Maxi, as well as colored impression trays (green, white, and blue) and related accessories. These devices are designed for dental impressions and mold-making procedures.

The company is headquartered in Hungary (HU), where it develops and manufactures its dental devices. Its location aligns with EU regulatory frameworks, which govern the classification and registration of its products.

Dentalia Dentálgyártmány Kft.’s devices are listed in the eudamed database, the EU’s central registry for medical devices. This platform ensures transparency and traceability of Class I devices authorized for use within the European Economic Area.

All of Dentalia Dentálgyártmány Kft.’s devices fall under Class I classification in the EU Medical Device Regulation (MDR). This classification applies to low-risk devices like dental molds and impression materials, which pose minimal risk to patients and require less stringent conformity assessment than higher-risk categories.