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VENTURA, Calif. -- The Med-Design Corporation, a leader in the design and development of safety needle products for medical use, today announced that the company has received 510(k) clearance from the Food and Drug Administration for Med-Design's Safety Dental Injector. The Safety Dental Injector is a one-handed, single-use, disposable syringe injector for the delivery of dental anesthetics.
As previously announced, 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 and medical products.
Med-Design will distribute the Safety Dental Injector through Sultan Chemists, a leader in the field of infection control and oral therapeutics. Sultan, as the exclusive worldwide distributor, will market the product to dentists, dental groups and government institutions through direct channels and established dental retailers.
"FDA 510(k) clearance is a critical step in bringing the Safety Dental Injector to the market," said David Dowsett, Med-Design's COO. "Because the November 2000 Needlestick Safety and Prevention Act and OSHA's blood borne pathogens standard clearly includes dentistry, many leading dentists have been looking for an effective way to render syringe injectors safe during and after patient use." Dowsett added, "Results of pre- clinical reviews show that dentists favor Med-Design's one-handed operation, which is consistent with current technique, while providing the safety aspect that dentists are seeking."
Upon completion of manufacturing ramp-up at Owens-Illinois, Med-Design and Sultan expect to begin initial shipments to customers in the second quarter 2003.
Source: Med-Design Corporation