BLUE SKY BIO LLC

Blue Sky Bio LLC specializes in dental implant-related devices. Their portfolio includes permanent preformed dental implant suprastructures, two-piece screw endosteal dental implants, reusable fixture/appliance drill bits, dental implant analogs, ceramic materials for dental appliance fabrication, suprastructure kits, guided surgery reference pins, and surgical torque wrench adaptors. These products are designed to support dental restoration procedures and surgical precision.

Blue Sky Bio LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support related to its dental implant devices.

Blue Sky Bio LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, ensuring they can verify the identity and regulatory status of the devices in use.

Blue Sky Bio LLC’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s purpose, intended use, and potential risks.