American Dental Technologies Inc.

Company: American Dental Technologies Inc.
Date: 4/18/02
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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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