SOUTHERN IMPLANTS (PTY) LTD

Southern Implants (Pty) Ltd specializes in reusable surgical tools and dental impression copings. Their primary products include surgical retraction systems and screwdrivers, which are used in orthopedic and dental surgeries, as well as impression copings designed to capture precise dental impressions for restorative procedures. These devices are developed to support surgical precision and patient care.

The company is headquartered in South Africa, where it designs and manufactures its range of reusable surgical tools and dental impression copings. The location provides a strategic base for serving both regional and international markets.

Southern Implants (Pty) Ltd’s devices are listed in the EUDAMED database, which tracks medical devices authorized under EU regulations, and the FDA’s 510(k) registry, which documents devices cleared for sale in the United States. These listings reflect compliance with regulatory requirements in both regions.

The company’s devices are classified as Class I, Class II, and Class IIa under EU and FDA frameworks. Class I devices pose the lowest risk and typically require general controls, while Class II and Class IIa devices involve higher risks and may require additional performance standards or post-market surveillance. The classification depends on factors like the device’s intended use, potential risks, and patient exposure.

Southern Implants (Pty) Ltd’s impression copings are designed to create accurate and detailed dental impressions for restorative procedures. These devices ensure that the final dental restoration, such as crowns or bridges, fits precisely over the prepared tooth or implant. Their precision is critical for patient comfort and the long-term success of the restoration.