Biolase FDA Clearance

The new clearance paves the way for dentists to perform additional procedures with the Waterlase (TM) system. The Waterlase (TM) is the first laser to receive clearance for these new bone, periodontal and general soft tissue surgical indications: Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours); Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc); Osseous crown lengthening; Flap preparation -- incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions); Full thickness flap; Partial thickness flap; Split thickness flap; Removal of granulation tissue from bony defects; and laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery.

Additionally, the Waterlase (TM) is the first hard tissue laser (YSGG or Er:YAG) to receive clearance for laser soft tissue curettage. BIOLASE's LaserSmile diode laser was previously cleared for laser soft tissue curettage in October 2003.

According to a report by the American Dental Association titled "1999 Survey of Dental Services Rendered" (updated in 2002), over 2.6 million osseous (bone) and gingival (gum) surgeries are performed each year by general practitioners, oral and maxillofacial surgeons and periodontists.

The clearance also covers soft tissue curettage for post extraction tooth socket. According to the ADA report more than 30 million tooth extractions are performed per year, which can now be treated with the Waterlase (TM).

A 1998 press release from the American Academy of Periodontology reported "A new analysis of recent research has revealed gum disease may represent a far more serious threat to the health of millions of Americans than previously realized. These studies found that periodontal (gum) infection may contribute to the development of heart disease, the nation's number one cause of death, increase the risk of premature, underweight births, and pose a serious threat to people whose health is already compromised due to diabetes and respiratory diseases."

Lawrence Nurin, D.D.S., commented, "These new indications are a major advancement for periodontists, general dentists and patients since procedures done with the Waterlase (TM) can be faster, cause significantly less post- operative pain and swelling and usually require little or no pain medication. The Waterlase (TM) gives dentists a way to avoid using scalpels and high speed drills. For example, instead of using a bur to grind bone to expose the underlying blood supply that will nourish a bone graft, now you can do the same procedure with the Waterlase (TM) without creating a smear layer, vibration or detrimental heat that will negatively impact tissue healing." Dr. Nurin has been practicing periodontics in Annapolis, Maryland since 1973.

Bret Dyer, D.D.S, added, "In addition to doing periodontal, soft tissue and bone procedures faster, with less trauma, less pain and with better, more predictable results than traditional methods, the Waterlase (TM) allows us to use techniques that were not previously possible. When performing Waterlase (TM) surgery there is less bleeding giving the doctor better visibility. Additionally, with the Waterlase (TM) we can now perform all of the following procedures -- cutting flaps, degranulating bone, recontouring bone, osseous surgery and perforating the bone to access the blood supply that previously would have required several different instruments. Another advantage of the new clearance and procedures is they allow practitioners to perform several procedures in one appointment in what previously may have required several appointments."