510(k) K192273

DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit by DiaDent Group International — Product Code KLE

K192273 is an FDA 510(k) premarket notification submitted by DiaDent Group International for the device "DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit". The FDA issued a decision of Substantially Equivalent on Feb 7, 2020. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. DiaDent Group International has 23 other 510(k) clearances on record.