Biolase, EdgeEndo root canal device gets FDA nod

By staff writers

January 6, 2022 -- The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Biolase and EdgeEndo's laser-assisted microfluidic irrigation device for disinfecting root canals.

Built upon Biolase's 2,780-mm wavelength laser technology, the EdgePro system uses laser light-sound technology and traditional irrigation solutions to kill up to 99% of bacteria commonly found in the root canal, according to the companies.

Biolase will manufacture the system, consumable procedure tips, and accompanying accessories for EdgeEndo, which will begin selling EdgePro and related products immediately within the U.S.

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