3D Global Biotech, Inc.

3D Global Biotech, Inc. specializes in orthodontic aligner systems, specifically the DailyMate and SmileAlign. These are clear, removable trays designed to gradually reposition teeth for dental correction, offering an alternative to traditional braces. They are intended for use in both adult and adolescent patients seeking discreet orthodontic treatment.

The company is headquartered in the United States. While the exact location isn’t specified, its operations and regulatory filings are conducted within the US, aligning with FDA requirements.

The orthodontic aligner systems produced by 3D Global Biotech, Inc., such as the DailyMate and SmileAlign, are classified as Class II medical devices under FDA regulations. This classification applies because these devices pose a moderate risk and require special controls to ensure their safety and effectiveness, beyond general controls. The 510(k) pathway is used to demonstrate that the devices are substantially equivalent to legally marketed predicates.

Yes, the company’s orthodontic aligner systems are listed in the FDA’s 510(k) database. This registry confirms that the devices have undergone the required premarket notification process, demonstrating compliance with US regulatory requirements before being authorised for commercial distribution.