As of May 2017, orthodontic labs are not required to be FDA approved due to an exception that was granted. The FDA regulates CAD/CAM technologies as well as aligner manufacturing in the dental laboratory under the FDA’s Title 21 CFR 820, which provides a framework for Current Good Manufacturing Practices (CGMP), and quality management procedures used in the manufacturing of Class II medical devices. ODL strictly follows this with the implementation of a Quality Management System.
ODL is also registered with the FDA for the manufacturing of a Class II medical device; Vivid Aligners. The 510(k) premarket notification can be found here:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190003