The T-8000 uses ordinary distilled water to create aqueous ozone potent enough to kill bacteria, viruses, and mold spores in dental-unit-waterlines and on instruments and surfaces.
Dr. Shenberg on FDA Clearance
On behalf of all TherOzone USA, Inc. employees and shareholders, it is our pleasure to announce that TherOzone has received FDA 510(k) clearance for the sale of our patent protected TherOzone T-8000 Unit.
This represents a significant milestone achieved for TherOzone, USA Inc. Not only does this give credibility to our product line and all it represents, but is also an important step forward in the growth of the company itself.
Over the next few months we are planning further significant moves forward for TherOzone USA, Inc.:
- Resume our manufacturing capability under Good Manufacturing Practices at the Sparton ISO 13485 certified medical device production facility in Irvine, CA
- Continue research and development for expanded and cost effective iterations of the T-8000
- Pursue CE Marking for the TherOzone T-8000 to support sales outside the United States
We want to thank everyone who has participated in the many years of work leading to this announcement. If you have any questions, please feel free to Contact Us.
With my utmost appreciation,
James E. Shenberg, DDS