510(k) K183424

Ambar, Ambar APS, Ambar Universal APS by Dentscare Ltda — Product Code KLE

K183424 is an FDA 510(k) premarket notification submitted by Dentscare Ltda for the device "Ambar, Ambar APS, Ambar Universal APS". The FDA issued a decision of Substantially Equivalent on December 13, 2019. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Dentscare Ltda has at least 9 other 510(k) clearances on record.