GEOMEDI INC.

Geomedi Inc. specializes in dental implant components. Their portfolio includes dental prosthesis/implant abutment screws, which secure prostheses to implants; dental implant suprastructures for permanent restorations; intraoral-scanning analogs used once during scanning procedures; and standard dental implant analogs. These devices support various stages of dental implant treatment, from initial placement to final restoration.

Geomedi Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their products as either Class I or Class II, depending on risk factors, and all listed devices appear in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking.

Geomedi Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling clear tracking, reporting, and compliance verification. This registry is critical for transparency in the medical device supply chain and regulatory oversight.

Geomedi Inc.’s devices fall under two FDA classification tiers: 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 depends on factors like the device’s intended use, potential harm, and clinical data, as outlined in FDA guidelines.

Geomedi Inc.’s intraoral-scanning analogs, such as the Geo Scanbody, are designed for single-use during digital scanning procedures. Unlike standard dental implant analogs used repeatedly in lab settings, these analogs are specifically engineered to provide accurate impressions for CAD/CAM technology, ensuring precise digital records for custom abutments or crowns without cross-contamination risks.