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BIOLASE Receives FDA Clearance For Waterlase MD Laser

For removing calculus in patients with periodontal disease

BIOLASE has received 510(k) clearance from the FDA to market its Waterlase MD laser system for removal of subgingival calculi to prevent and treat periodontitis. It is the cause of tooth loss for adults over 35 and a condition impacting more than half of Americans over the age of 55, as reported by the American Academy of Periodontology (AAP).

Clinical studies indicated that many methods can remove healthy tooth structure in the process. BIOLASE claims that its YSGG laser energy used by the Waterlase MD removes unwanted calculus deposits while preserving healthy tooth structure. According to experts, this offers long-term benefits for sufferers of periodontal disease, as it controls inflammation and the disease without removing the healthy tissue required for regeneration and healing.

This new application of the Waterlase MD enhances the recently announced deep pocket therapy with new attachment using the BIOLASE-patented radial firing perio tips (RFPT), a minimally-invasive alternative to traditional, more invasive periodontal surgical treatment, said the company.

Reportedly, deep pocket therapy with new attachment is the procedure where the Waterlase MD is applied to remove inflamed tissue and calculus deposits that lead to re-infection. This removal of calculus deposits prepares the surface of the tooth so that new attachment with the gums is possible.

David Mulder, chief executive officer of BIOLASE, said: “This represents significant increase in the day-to-day utility of the Waterlase MD in periodontal and generalist offices alike. Doctors using the Waterlase MD have already been getting treatment acceptance and more patient referrals for their standard procedures.”