Orthodent Laboratory, Inc.

Orthodent Laboratory, Inc. specializes in orthodontic progressive aligners, specifically clear dental aligners. These devices are designed to gradually move teeth incrementally as part of orthodontic treatment, helping patients achieve aligned smiles over time.

Orthodent Laboratory, Inc. is based in the United States. The company’s location is relevant for understanding regulatory oversight and compliance with US medical device regulations.

Orthodent Laboratory, Inc.’s orthodontic progressive aligners are classified as Class II devices in the US. This classification is determined by the FDA based on the level of risk associated with the device, where Class II devices require special controls beyond general controls to ensure safety and effectiveness.

Orthodent Laboratory, Inc.’s devices are listed under the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. The 510(k) process ensures that the devices meet FDA requirements for safety and performance before being marketed, while the UDI system provides a standardized identification for tracking and traceability.

The FDA’s 510(k) premarket notification process applies to Orthodent Laboratory, Inc.’s aligners because they are considered Class II devices. This process requires manufacturers to demonstrate that their device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. It ensures that incremental innovations in aligner technology still meet regulatory standards before entering the market.