Bio-Art Equipamentos Odontológicos Ltda.

Bio-Art Equipamentos Odontológicos Ltda. specializes in dental laboratory equipment, primarily producing vacuum forming sheets and articulator accessories. These include items like the Fox Ruler and kits for articulators, such as the Camper’s table with fork support. These products are designed to assist dental professionals in creating custom prosthetics and orthodontic appliances.

The company is based in Brazil, as indicated by its country designation. This geographical location influences its regulatory compliance and market focus, particularly in Latin America and potentially other regions where its devices are distributed.

Bio-Art’s devices are listed in the eudamed registry, which is the European database for medical devices. This registry is used to track devices authorized for placement on the EU market, ensuring transparency and traceability for healthcare professionals and regulators.

Bio-Art’s products are classified as Class I medical devices. This classification is typically assigned to low-risk items like dental laboratory accessories, which pose minimal risk to patients when used as intended. Class I devices often require less stringent regulatory oversight compared to higher-risk categories.