S.I.N. - Sistema DE Implante Nacional S.A.

S.I.N. specializes in dental implants and associated components. Their product range includes one-piece screw endosteal dental implants, permanent and temporary preformed suprastructures for dental prosthetics, reusable surgical tools like drill bits and screwdrivers, and reusable depth/angle gauges for precise dental procedures. They also produce single-use items such as dental abutment screw analogs and reusable non-medicated surgical kits for maxillofacial applications. These devices support dental restoration, implant placement, and surgical guidance.

The company is based in the United States. This location allows them to comply with U.S. regulatory requirements for medical devices, including classification under FDA guidelines and potential UDI listing for traceability and post-market surveillance.

S.I.N.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures standardized identification of medical devices, facilitating tracking, regulatory compliance, and transparency in the supply chain. This registry is critical for monitoring device performance, recalls, and post-market reporting.

S.I.N.’s devices fall under Class I and Class II classifications under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with (e.g., dental implants are typically Class II due to their invasive nature and long-term use).

S.I.N. manufactures both reusable and single-use dental devices to cater to different clinical needs and infection control protocols. Reusable items like drill bits, screwdrivers, and depth/angle gauges are designed for durability and sterilization between uses, reducing waste and costs. In contrast, single-use devices such as abutment screw analogs and non-medicated surgical kits are intended for one-time use to minimize cross-contamination risks, ensuring patient safety in procedures like implant placement or maxillofacial surgeries.