Recipient: Millennium Dental Technologies Inc
Product: Medical devices
Date: 6/7/05

Our inspection found the following device QSR deficiencies
Software used as part of the quality system has not been validated for its intended use according to an established protocol. Specifically, you are using a software system for your procedures that allows procedures to have inconsistent effective, approved and release dates. [21 CFR 820.70(i)]

FDA District: Los Angeles District Office