ASI Medical, Inc. – FDA Warning Letter, Dec 22, 2011

On December 19-22, 2011, an FDA inspection of ASI Medical, Inc. in Centennial, Colorado, revealed that the firm manufactures Advance Dental Classic Series Dental Carts and Advanced Dental Designer Series Dental Carts, which are medical devices. The firm submitted 510(k) applications for these products, but they were not cleared. Consequently, ASI Medical, Inc. has been distributing Advance Model Dental Units since 2010 without FDA marketing clearances.

These devices are adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption. They are also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the devices into commercial distribution, as required by section 510(k).

ASI Medical, Inc. must immediately cease distribution of these devices and take prompt action to correct the violations. Failure to comply may result in regulatory actions including seizure, injunction, civil money penalties, and federal agencies being advised when considering contracts. The firm must respond in writing within fifteen business days, detailing corrective steps, prevention plans, and a timetable for implementation, including documentation. The response should be sent to the FDA's Center for Devices and Radiological Health, Office of Compliance. This letter is not an exhaustive list of violations; the firm is responsible for ensuring full compliance.