VENTURA, Calif. -- The Med-Design Corporation, a leader in the design and development of safety-engineered needle products for medical use, today announced the submission of a request for 510(k) clearance from the Food and Drug Administration (FDA) for Med-Design's Safety Dental Injector on Sept. 6, 2002. The Safety Dental Injector is a one-handed, single-use, disposable syringe injector for the delivery of dental anesthetics.
Sultan Chemists of Englewood, N.J. will serve as the exclusive distributor of the product for Med-Design. Sultan, a leader in the field of infection control and oral therapeutics, will market the Safety Dental Injector directly to dentists and distribute the product through established dental product distributors.
The Safety Dental Injector will be manufactured by Owens-Illinois using equipment designed and owned by Med-Design. Owens-Illinois, based in Toledo, Ohio, is one of the world's leading manufacturers of glass and plastic packaging.
If regulatory clearance is obtained by the end of 2002, Med-Design and Sultan will begin shipping the Safety Dental Injector to customers in the first quarter of 2003.
"Submitting this 510(k) to the FDA is an important milestone for Med-Design because the Safety Dental Injector represents the first product to be developed and released under Med-Design's gross margin business model," said David Dowsett, Med-Design's COO. "In cooperation with strong partners in both the manufacturing and the sales and marketing of the product, Med-Design will be able to grow sales and gross margin without the overhead of internal manufacturing and sales organizations.
"Results of pre-clinical reviews of the product show that dentists favor a one-handed, lightweight syringe injector," Dowsett added. "We believe the Safety Dental Injector will be a useful tool to dental practitioners, with a market that Sultan estimates to be in excess of 75 million units annually."
Founded in 1990, the Med-Design Corporation has developed technology related to 38 safety needle products designed to enable medical workers to perform a wide range of medical procedures with products that retract the needle into a protective housing rendering the contaminated needle inoperative. Med-Design's safety needle products and technologies cover applications within the important risk areas of blood collection, infusion therapy, venous and arterial insertion, and injection. Med-Design develops user-friendly and cost-effective safety needle devices and technologies, utilizing its expertise in creating technology for products that meet stringent user requirements, while minimizing manufacturing cost. Med-Design has a significant portfolio of issued and pending patents protecting its proprietary safety needle technology. Approximately half of Med-Design's product designs have been licensed. Med-Design is actively seeking partners for its remaining products and designs.