DENTSPLY International Inc. Announces FDA Approval of Expanded Indications for PepGen P-15 And PepGen P-15 Flow.Business Editors/Health & Medical Writers DENTSPLY International Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :XRAY) today announced that the Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. (CDRH) of the Food and Drug Administration (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. ) has approved DENTSPLY Ceramed's premarket approval application (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) supplement for three additional indications for use of its PepGen P-15(TM) and PepGen P-15 Flow(TM) products. The three additional indications include: augmentation of boney defects of the alveolar ridge, filling tooth extraction sites and sinus elevation grafting. DENTSPLY was also notified by the American Dental Association American Dental Association (ADA), n.pr a nonprofit professional association whose membership is dental professionals in the United States. Its purpose is to assist its members in providing the highest professional and ethical care to the citizens of the (ADA Ada, city, United States Ada (ā`ə), city (1990 pop. 15,820), seat of Pontotoc co., S central Okla.; inc. 1904. It is a large cattle market and the center of a rich oil and ranch area. ) that they have awarded their seal of acceptance to the PepGen P-15(TM) and PepGen P-15 Flow(TM). These are the only bone grafting materials to be so recognized by the ADA. John C. Miles, II, Chairman and Chief Executive Officer, stated, "We are very excited with the expanded opportunities these new FDA approved indications bring to an already powerful and well recognized product offering. We are also currently combining our Ceramed (PepGen P-15(TM) and Friadent (implant) divisions in the U.S. to take advantage of a larger sales force armed with a stronger arsenal of products. We expect this enlarged sales force will not only help expand our PepGen P-15(TM) sales, but will also allow us to accelerate our market share gains within the dental implant market." 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 paste, dental sealants, ultrasonic scalers, dental injectible anesthetics 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 holders, film mounts and bone substitute/grafting materials; and a leading worldwide manufacturer or distributor of impression materials, orthodontic 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. |
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