LASCOD S.P.A. (LABORATORI SCIENTIFICI ODONTOIATRIA)

LASCOD S.P.A. specializes in dental impression materials, primarily focusing on silicone-based products and alginate pastes. Their portfolio includes silicone putty and regular body formulations for dental molds, as well as fast-set and normal-set silicone materials for occlusal registration. They also produce alginate impression pastes in both chromatic and non-chromatic variants, catering to orthodontic and general dental applications. These materials are designed for creating precise dental impressions in clinical settings.

LASCOD S.P.A. is based in Italy and operates within the European Union’s medical device regulatory framework. Their devices are intended for use in the EU market, where they must comply with EU medical device regulations. The company’s products are registered in the EUDAMED database, which is the official EU registry for medical devices, ensuring transparency and traceability of their offerings.

LASCOD S.P.A.’s devices are listed in the EUDAMED database under the Devices section, specifically in the Class I category. EUDAMED is the official EU registry for medical devices, and all Class I devices—including dental impression materials—must be registered here to comply with EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements. Registration ensures traceability and transparency for regulatory oversight.

LASCOD S.P.A.’s dental impression materials are classified as EU Class I devices. This classification applies because they are low-risk products used for diagnostic or monitoring purposes in dentistry, such as creating molds for dental prosthetics or orthodontic appliances. Class I devices typically require less stringent regulatory scrutiny than higher-risk categories but still must meet essential safety and performance requirements to ensure patient safety and clinical effectiveness.