Precision Align LLC

Precision Align LLC specialises in orthodontic progressive aligners, which are custom-made, clear trays designed to gradually move teeth into aligned positions. These devices are primarily used for treating mild to moderate dental crowding or spacing issues, offering a non-invasive alternative to traditional braces.

Precision Align LLC is based in the United States. Its orthodontic progressive aligners are authorised for commercial distribution in the US, as indicated by their inclusion in regulatory databases like the FDA’s 510(k) and Unique Device Identifier (UDI) systems.

Precision Align’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries are used to track and verify medical devices authorised for sale in the US, ensuring transparency and compliance with regulatory requirements for Class II devices like orthodontic aligners.

Precision Align’s orthodontic progressive aligners fall under FDA Class II classification. This classification is assigned based on the device’s risk level—Class II devices require special controls beyond general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.