American Dental Technologies Receives Clearance for Laser Removal of Enamel Dental Decay.SOUTHFIELD, Mich.--(BW HealthWire)--May 19, 1999-- New Application Selectively Vaporizes Surface Caries caries or tooth decay Localized disease that causes decay and cavities in teeth. It begins at the tooth's surface and may penetrate the dentin and the pulp cavity. , Requires No Special Handpiece Tip American Dental Technologies, Inc. (Nasdaq:ADLI) announced today 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 granted the Company 510(k) clearance to market its PulseMaster Nd:YAG lasers PulseMaster Nd:YAG laser Dentistry A laser used for aphthous ulcers, soft-tissue procedures–eg, frenectomy, ↓ hyperplastic tissue, access gum-covered decay, treat gum disease, for cosmetic soft-tissue recontouring, decay removal in caries. See Y laser. for selective removal of enamel (first degree) dental caries. "We regard this hard tissue clearance as a milestone in laser dentistry laser dentistry Dentistry Any use of lasers in dentistry–eg, zapping caries, cosmetic dentistry. See Cosmetic dentistry. because it is the first clearance for this specific indication for use," said Ben Gallant, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "And as the first Nd:YAG laser to be granted a hard tissue marketing clearance for use on patients of all ages, it acknowledges the PulseMaster's unique ability to selectively remove decay while keeping healthy enamel intact. And it further demonstrates our company philosophy of offering beneficial and clinically significant instruments that intercept dental disease A dental disease is a disease which affects the teeth or gums. Some of the most prevalent types of dental disease include dental caries (also known as tooth decay), and gum disease. at the earliest time possible." "The PulseMaster laser has the ability to selectively remove the very beginning stages of tooth decay Tooth Decay Definition Tooth decay, which is also called dental cavities or dental caries, is the destruction of the outer surface (enamel) of a tooth. -- caries which is confined to enamel, the outer layer of the tooth," noted Terry D. Myers, DDS (1) (Digital Data Storage) See DAT. (2) (Data Dictionary System) See QuickBuild and OpenDDS. (3) (Dataphone Digital S , American Dental Technologies' Vice President, Research and Clinical Affairs and co-developer of the world's first dental laser A dental laser is a type of laser designed specifically for use in oral surgery. In the United States, the use of lasers on the gums was first approved by the Food and Drug Administration in the early 1990s, and use on hard tissue like teeth or the bone of the mandible gained designed specifically for general dentistry. "The pulsed Nd:YAG laser beam interacts with the dark organic material of decay, selectively vaporizing it, leaving the adjacent sound, healthy enamel unaffected. This offers a more conservative treatment alternative than other laser types which have been previously cleared for caries removal and cavity preparation." "This latest clearance reinforces our well-established belief that the pulsed Nd:YAG laser is arguably the most versatile dental laser for treating dental disease," said Mr. Gallant. "The selective aspect of decay removal essentially makes this fundamentally new technology. Whereas other dental devices -- the conventional dental drill, erbium erbium (ûr`bēəm) [from Ytterby, a town in Sweden], metallic chemical element; symbol Er; at. no. 68; at. wt. 167.26; m.p. 1,529°C;; b.p. 2,863°C;; sp. gr. 9.05 at 25°C;; valence +3. laser, even air abrasion instruments -- simultaneously remove decay and make cavity preparations, the PulseMaster is designed to remove the decayed tissue only, offering the most conservative treatment available." Significantly, the laser's interaction with the decay is self-limiting. Once the decay has been selectively removed, the sound, flashing, and pulsing sensation stop because the laser does not interact with sound tooth enamel. So the clinician has audible, visual, and tactile indicators of when the treatment objective of caries removal has been achieved. The procedure usually can be performed without the need for anesthesia. Unlike the erbium laser, the PulseMaster Nd:YAG laser requires no special handpiece tip that needs replacement or reconditioning after several cavity preparations. The selective removal of decay with the PulseMaster is therefore both an economical and ultra-conservative method to treat tooth decay at its earliest stage of development. This marketing clearance marks the culmination of some 10 years of university-based laboratory studies and human clinical trials using pulsed Nd:YAG dental lasers from American Dental Technologies to help establish their safety and efficacy for use on hard tissue. American Dental Technologies, headquartered in Southfield, Michigan, develops and manufactures advanced technologies for dentistry and markets them worldwide. It is listed on the Nasdaq National Market under the symbol ADLI. Its website is found at www.americandentaltech.com |
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