INDUSTRIA ZINGARDI S.R.L.

Industria Zingardi S.R.L. specializes in dental impression materials and orthodontic wax products. Their portfolio includes items like orthodontic ceramic strips (such as CURASEPT CERA ORTODONTICA), hard and soft bite wax (e.g., BITE WAX), colored modeling wax (like CERA NERA IN PANI), dental plate wax (PLATEWAX HARD NORMAL), and dental wax tampons for laboratory use (e.g., TAMPONI CERA LAB SOFT CURVI). These products are designed for dental and orthodontic applications.

Industria Zingardi S.R.L. is based in Italy. The company’s location is relevant for understanding its regulatory framework, as it operates under the EU Medical Device Regulation (MDR) and registers its devices in the EUDAMED database.

Industria Zingardi S.R.L.’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry allows healthcare professionals, regulators, and other stakeholders to verify the manufacturer and device details, including classification and compliance information.

All of Industria Zingardi S.R.L.’s devices fall under EU Medical Device Regulation Class I. This classification applies to low-risk devices, such as dental impression materials and orthodontic wax products, which are generally considered safe for their intended use without active or invasive features. The classification determines the regulatory requirements for authorization and post-market surveillance.