Company: American Dental Technologies Inc.
Product: Dental device systems, including PulseMaster 600-IQ and DioLase ST Dental Laser System, PowerPAC High Speed Curing Light System, KCP 5 and 1000 Air Abrasive Kinetic Cavity Preparation System and Ultracam Intraoral Camera System
Failure to maintain adequate device master records [21 CFR 820.181] [FDA- 483 Item 5]. For example, your firm did not maintain or refer to the location of the software engineering change records and software testing procedures.
FDA District: Dallas District Office