BIOLASE receives FDA approval for bone-benefitting laser

Feb. 26, 2002
It is the first-ever clearance from the FDA for laser cutting, shaving, contouring and resection of oral osseous tissues (bone).

BIOLASE Technology, Inc., a medical technology company focused on the dental laser market, has announced that it has obtained the first-ever clearance from the U.S. Food and Drug Administration (FDA) for laser cutting, shaving, contouring and resection of oral osseous tissues (bone).

Jeffrey W. Jones, BIOLASE CEO and president, commented, "This additional new bone clearance further expands the marketable, multiple uses of the Waterlase(TM), making it even more profitable and appealing for dentists to purchase the system. It gives general dentists the ability to easily do procedures they would either normally refer out to specialists, or ignore, resulting in tens of thousands of dollars of incremental revenue for their practices. As an example, the majority of dentists can perform at least two bone cases per week at fees of $500 to $750 per procedure, growing their annual revenue by $50,000 to $75,000 on an investment of $1,000 per month. With 120,000 general dentists and 30,000 specialists in the U.S., the market for these new advanced procedures is very significant."

Malcolm B. Zola, DDS, Chief, Section of Oral & Maxillofacial Surgery, Department of Dentistry, St. Barnabas Hospital, New York, commented, "The Waterlase has proven to be especially successful in removing bone during surgical procedures. The inadvertent injury to adjacent structures, which has often resulted in the past from the use of a high-speed drill, was completely avoided. Since water is the actual cutting tool, there was no charring or burning of hard tissues, which sometimes accompanies the use of a drill."

Dr. Zola added, "Finally, and most importantly, our patients were seen at one-day, one-week, and two-week intervals after surgery. Post-operative pain was almost non-existent; edema was little-to-none, healing was excellent, and patient's appreciation of the gentleness of their surgery and the benignity of their post operative course was universal."

According to Dara Rosenberg, DDS, MPH, MS, Director, Department of Dentistry, St. Barnabas Hospital, "We have used the Waterlase for a number of years. With the Waterlase, surgeries can now be performed with more control than with high-speed drills, and patients most often have pain-free recuperation. With the addition of the new clearances on its use for root canal and bone cutting, the WaterLase should be able to play a major role in refining and enhancing every dentist's current operative and surgical techniques."

"Waterlase is a revolutionary tool for dental procedures that require cutting or shaving bone structure," commented William Greider, DMD, MAGD and Brendan Dwyer, DDS, FAGD, Ft. Myers, Florida. "When cutting bone with a dental bur, the resulting trauma can cause necrosis, compromising final results. From our experience, bone procedures done with the Waterlase produce significantly better and more predictable results and allows patients to undergo significant surgical procedures with dramatically fewer complications and little or no post-operative pain. Additionally, bone procedures can be done much less invasively often resulting in faster healing. The Waterlase allows us to save teeth that used to be unsalvageable using traditional methods."

William H. Chen, DMD, MAGD, commented, "I strongly believe that dentistry is going through a significant revolution with the advancement of this innovative laser technology to cut bone and other hard- and soft-tissues. Laser surgery is less traumatic and provides the patient with better post-op comfort and faster recovery."

Dr. Chen concluded, "I have been using the Waterlase to cut, remove and re-contour bone in dental surgical procedures such as crown lengthening, bone reduction in impacted third molar extractions, endodontic root end surgeries and periodontal surgeries. I have seen a reduction in the need for prescription pain medication and complications including excessive bleeding, inflammation, swelling, and bruising are significantly reduced."

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