Gro3x, Inc.

Gro3x, Inc. specializes in dental milling systems with CAD/CAM technology, specifically designed for chairside use. These systems allow dental professionals to create dental restorations directly in the office, improving efficiency and patient care. The primary focus is on in-office fabrication solutions for dental applications.

Gro3x, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database includes Gro3x’s products, which helps ensure traceability and compliance with U.S. medical device requirements.

Gro3x’s devices are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness. The specific controls for Class II devices may include performance standards, post-market surveillance, or labeling requirements.

Yes, Gro3x’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is crucial because it provides a standardized way to identify medical devices throughout their lifecycle, from manufacturing to post-market surveillance. Listing in the UDI database helps ensure transparency, traceability, and compliance with regulatory requirements.