Business Services Industry
Lifecore Granted 510k Marketing Clearance for Stage-1 Single Stage Dental Implant System
Business Wire, July 20, 1999
CHASKA, Minn.--(BUSINESS WIRE)--July 20, 1999--
Lifecore Biomedical, Inc. (Nasdaq:LCBM) announced today that the U.S. Food and Drug Administration has granted 510(k) marketing clearance for the Company's new Stage-1(TM) Single Stage Dental Implant System.
Lifecore's new Stage-1(TM) Single Stage System incorporates existing, well-accepted features similar to other current systems, but adds novel design and patent-pending packaging features that enhance user convenience. This state-of-the-art design joins a single stage implant product category that has rapidly grown to comprise approximately 14 percent of the $500 million global dental implant market.
Lifecore expects to introduce the Stage-1(TM) System at several national professional meetings in September, including the AAP (American Association of Periodontology); the AAOMS (American Association of Oral and Maxillofacial Surgeons); and the AAID (American Academy of Implant Dentistry).
Dental implants are permanent titanium metal implants that replace missing teeth. Most conventional dental implant systems use a two-stage implementation process. In those two-stage systems a permanent root-like implant is first fitted into the jawbone. Later, a second surgery is performed to prepare the implanted component for prosthetic restoration with a replacement "false" tooth. Recently, dental implant surgeons have begun to use single-stage implant systems that eliminate the second surgical procedure and simplify the prosthetic restoration procedure for both the patient and the dental clinician.
Lifecore Biomedical manufactures biomaterials for use in various surgical devices.
Additional news and general information are available through the Company's website at http://www.lifecore.com.
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