Phase Ortho, Inc.

Phase Ortho, Inc. specializes in orthodontic devices, primarily producing progressive aligners and retainers. Their aligners are designed for gradual teeth movement to achieve straighter smiles, while their retainers help maintain dental positioning after orthodontic treatment. These devices are tailored for both adult and pediatric patients, including custom-branded and private-label solutions.

Phase Ortho, Inc. is based in the United States, which means its devices are subject to FDA regulations under the US Food and Drug Act. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they comply with mandatory UDI requirements for medical devices in the US, ensuring traceability and regulatory transparency.

Phase Ortho, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing is mandatory for Class I and Class II devices in the US, ensuring that each product has a unique identifier for tracking, compliance, and regulatory purposes. The UDI system helps streamline post-market surveillance and reporting.

Phase Ortho, Inc.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional controls due to moderate risk. Orthodontic aligners and retainers are typically classified based on their intended use and potential impact on patient safety, with aligners often falling into Class II due to their active role in teeth movement.