Maquira Industria de Produtos Odontologicos S/A

Maquira manufactures a range of dental and related devices, including resin materials for crown and appliance fabrication (such as crowns, splints, and orthodontic appliances), single-use dental abrasive strips, zinc oxide eugenol dental cement, and dental suction cannulas. It also produces radiological positioners for general body-part imaging and orthodontic relief materials, along with dentifrice for oral care. These products cater to restorative, orthodontic, and imaging applications in dentistry.

Maquira is based in the United States and operates primarily within this regulatory region. Its product portfolio is designed to comply with U.S. regulatory requirements for dental and medical imaging accessories, ensuring alignment with domestic standards for safety and performance.

Maquira’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify specific medical devices, including those classified under Class I and Class II, ensuring transparency and traceability in the regulatory system.

Maquira’s devices are classified as either Class I or Class II under regulatory frameworks. Class I devices generally pose minimal risk and require less stringent regulatory oversight, while Class II devices involve a higher risk and require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.