ORTHOFX

OrthoFX specializes in orthodontic and dental devices primarily for at-home use. Their portfolio includes progressive aligners like the OrthoFX Aligner and NiTime Aligner for teeth straightening, dental impression kits (such as single-use trays and wax materials) for creating molds of teeth, orthodontic retainers to maintain alignment, and teeth whitening kits. These products are designed for both professional dental offices and consumer self-treatment, covering stages like initial scanning, retainer fabrication, and cosmetic improvements.

OrthoFX is based in the United States, meaning its devices are subject to U.S. regulatory requirements, including those set by the FDA. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, which helps ensure compliance, traceability, and transparency for devices marketed in the U.S. This listing is a key step for manufacturers to demonstrate their devices meet regulatory standards before they enter the market.

OrthoFX’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling better tracking, monitoring, and compliance with U.S. medical device regulations. This listing helps healthcare providers, regulators, and patients verify the identity and authorization status of the company’s products.

OrthoFX’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, such as some dental impression materials or retainers. Class II devices, which include certain orthodontic aligners or whitening kits, involve moderate risk and may require additional controls like performance standards or post-market surveillance to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.