DENTSPLY International Inc. Reports FDA Approval of Oraqix --Lidocaine and Prilocaine Gel-- 2.5%/2.5%.Business Editors/Health/Medical Writers YORK, Pa.--(BUSINESS WIRE)--Jan. 8, 2004 DENTSPLY International Inc. (Nasdaq:XRAY) today announced that it has received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval for Oraqix(R), its revolutionary new non-injectable anesthetic for periodontal periodontal /peri·odon·tal/ (per?e-o-don´t'l) 1. pertaining to the periodontal ligament or periodontium. 2. near or around a tooth. per·i·o·don·tal adj. 1. applications. The anesthetic is delivered to the treatment site without the use of a needle and anesthetizes the site within 30 seconds for a period of approximately 20 minutes. Gary K. Kunkle, Vice-Chairman and Chief Executive Officer commented that, "We are extremely pleased to receive regulatory approval to bring this exciting new product to market in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . It brings a tremendous benefit to the millions of patients that desire an alternative anesthetic that can be administered without an injection and to those that simply reject the use of anesthetic to avoid the injection." The Company will immediately begin the development of manufacturing molds and other related equipment as required by agreements with the FDA. Following manufacturing validation, a launch of Oraqix in the United States is expected in the second half of the year. Regulatory approval has already been granted in Sweden, the reference member state in Europe for the product. Additional approvals are expected throughout Europe during the year and the launch of Oraqix in the EU will be determined as these approvals are received. DENTSPLY designs, develops, manufactures and markets a broad range of products for the dental market. The Company believes that it is the world's leading manufacturer and distributor of dental prosthetics, precious metal dental alloys, dental ceramics, endodontic Endodontic Pertaining to the inside structures of the tooth, including the dental pulp and tooth root, and the periapical tissue surrounding the root. Mentioned in: Root Canal Treatment endodontic instruments and materials, prophylaxis prophylaxis (prō'fĭlăk`sĭs), measures designed to prevent the occurrence of disease or its dissemination. Some examples of prophylaxis are immunization against serious diseases such as smallpox or diphtheria; quarantine to confine paste, dental sealants, ultrasonic scalers, and crown and bridge materials; the leading United States manufacturer and distributor of dental x-ray equipment, dental handpieces, intraoral cameras, dental x-ray film Noun 1. X-ray film - photographic film used to make X-ray pictures bitewing - a dental X-ray film that can be held in place by the teeth during radiography holders, film mounts and bone substitute/grafting materials; and a leading worldwide manufacturer or distributor of dental injectible anesthetics Anesthetics Drugs or methodologies used to make a body area free of sensation or pain. Mentioned in: Appendectomy , impression materials, orthodontic orthodontic (ôr´th adj appliances, dental cutting instruments and dental implants. The Company distributes its dental products in over 120 countries under some of the most well established brand names in the industry. DENTSPLY is committed to the development of innovative, high quality, cost-effective new products for the dental market. This press release contains forward-looking statements regarding future events or the future financial performance of the company. Actual events or results may differ materially from those in the projections or other forward-looking statements set forth herein as a result of certain risk factors. These risk factors include without limitation; the continued strength of dental markets, the timing, success and market reception for our new product introductions, and changes in the general economic environment that could affect our business. For an additional description of risk factors, please refer to the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed with the Securities and Exchange Commission. |
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