Convergent Dental Receives Second 510(k) Solea Clearance for Dental Enamel Protection
Needham, Mass.-based Convergent Dental has received 510(k) clearance from the FDA for its Solea All-Tissue Dental Laser, a 9.3 micrometer carbon dioxide laser for a new indication — dental enamel mineral loss reduction to help protect teeth against the effects of acid and caries development.
The Solea product is also used to treat soft and hard dental tissue and to enable cavity prep without anesthesia. The treatment is suture-free with minimal post-operative discomfort and rapid healing, the company said.
The mineral loss reduction laser treatment will be made commercially available in the U.S. on a limited basis starting this month and will be fully available in 2023.