Date: September 11, 2002
Subject: FDA Site Inspection and Certification
Contact: Delwin K. McCarthy, DDS
Millennium Dental Technologies, announced today that it has passed the site inspection for the U.S. Food and Drug Administration's for Good Manufacturing Practices (GMP's), and Quality Assurances for manufacturing the PerioLase II digital pulsed Nd:YAG dental laser for the treatment of Laser Periodontal Therapy at its facilities in Cerritos, California. The certification is necessary for a federal license to manufacture FDA 510(k) cleared medical devices.
This certification comes on the heals of receiving a similar license to manufacture from the Food and Drug Branch of the Department of Health Services of the state of California.
Dr. McCarthy, Chief of Operations for Millennium said about the FDA approval process of getting 510(k) device clearance then having to pass two back-to-back rigorous site inspections, "It's a little like getting your college diploma, then spending a lot of time justifying why you deserve it and why you should be allowed to keep it!"
The FDA's certification is valid for two years.
Delwin K. McCarthy, DDS