SIC invent AG

SIC invent AG specializes in dental implant components. Their product range includes permanent and temporary preformed suprastructures for dental implants, two-piece screw endosteal dental implants, reusable dental drill bits, bar dental precision attachments, reusable holding endpieces, implant extractors, and dental implant analogs used in laboratory settings. These devices support various stages of dental implant procedures, from initial placement to final restoration.

SIC invent AG is based in the United States. Since the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, this indicates their products are intended for the US market and must comply with FDA regulations. The FDA classifies their devices as either Class I or Class II, which determines the level of regulatory oversight and requirements for premarket submission.

SIC invent AG’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and clinical purposes. This listing is specific to the US market and reflects compliance with FDA requirements for device identification.

SIC invent AG’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as whether a 510(k) premarket notification submission is required for Class II devices, whereas Class I devices may only need registration and listing.

Listing in the FDA’s UDI database means that each of SIC invent AG’s devices has been assigned a unique identifier, combining a device identifier and a production identifier. This system improves patient safety, enhances regulatory oversight, and facilitates better tracking of devices in the supply chain. It also helps healthcare providers and regulators quickly access critical information about the device, such as its manufacturer, model, and batch details, ensuring compliance with FDA requirements for medical device traceability.