WOLF INDUSTRIES, INC.
NEWS RELEASE
December 8, 1998
Wolf Industries Receives Favorable FDA
Notice Re: Dental Color Analyzer
DCA Cleared for Commercialization
SEATTLE, WA, DECEMBER 8, 1998…. Wolf Industries' President Patrick McGowan announced this morning that the Company has received notice from the U.S. Food and Drug Administration (the "FDA") regarding the planned commercialization of the Company's first product, the Dental Color Analyzer ("DCA").
Mr. McGowan said, "The FDA has determined that the DCA is not a "medical device", in that it is "not indicated for any medical uses" and non-invasive. Importantly, we also learned that the FDA will not require any further review of the DCA. We have always considered the DCA to be a non-invasive and risk-free device designed for specific applications within cosmetic dentistry."
Mr. McGowan continued, "We are pleased with the FDA's determination and look forward to having the first 750 units delivered to our network of outstanding dentists and clinicians throughout the United States and Canada in the near future. This represents the clearance of a major hurdle in the development of the DCA and the beginning of our marketing and commercialization program."
Wolf Industries Inc., is a dental technology company with worldwide manufacturing and marketing rights to the DCA (Dental Color Analyzer), a leading edge technology to the dental industry which utilizes optical fiber spectroscopy for use in determining accurate, true measurement of shades and colors of dental materials.
The DCA has been developed to assist dentists in determining accurate and true measurement of shade and colors of dental materials. To date, the dental industry has relied primarily on visual interpretation of tooth shades for restorative dental work. The DCA, for which there is a patent pending, employs optical fiber spectroscopy to determine the exact shade of the original tooth. It determines the shades and colors of dental material used in replacement work in dentistry, and precisely matches these shades to original teeth.
Certain information included in this communication (as well as information included in oral statements or other written statements made or to be made by Wolf Industries) contains statements that are forward-looking, such as statements relating to the future anticipated direction of the dental industry, plans for future expansion, various business development activities, planned capital expenditures, future-funding sources, anticipated sales growth and potential contracts. These forward statements are subject to a number of known and unknown risks and uncertainties that could cause actual operations or results to differ materially from those anticipated.
Wolf Industries Inc.'s World Wide Web address is: wolfindustries.com
For further information: Amanda Marley-Clarke, 1-888-253-6657 |
