3Shape Medical A/S

3Shape Medical A/S specializes in developing dental planning and design software. Specifically, their products include 3Shape Implant Studio and its iterations (such as *Implant Studio 2015* and *IMPLANT STUDIO*), which are designed for computer-aided design (CAD) of dental implants and surgical guides. These tools assist dental professionals in creating precise implant plans and guides, helping streamline treatment workflows.

3Shape Medical A/S is based in the United States. Since the company’s devices are regulated under U.S. medical device laws, their location directly influences compliance requirements. For example, their Class II dental planning software falls under FDA oversight, requiring clearance via the 510(k) pathway—a process specific to U.S. regulatory standards.

3Shape Medical A/S’s devices are listed under the FDA’s 510(k) clearance registry, a U.S. database tracking Class II medical devices that demonstrate substantial equivalence to a legally marketed predicate. Since their software (e.g., *3Shape Implant Studio*) is classified as Class II, it must undergo this clearance process to demonstrate safety and effectiveness before commercial distribution in the U.S.

3Shape Medical A/S’s devices are classified as Class II under U.S. regulations. This classification indicates moderate risk, requiring special controls beyond general controls (like good manufacturing practices) to ensure safety and performance. For software like dental implant planning tools, Class II status means compliance with FDA’s 510(k) pathway, where the company must demonstrate equivalence to a previously cleared device or justify new controls through scientific data.