510(k) K200555

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) by Prevest Denpro Limited — Product Code EMA

K200555 is an FDA 510(k) premarket notification submitted by Prevest Denpro Limited for the device "Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)". The FDA issued a decision of Substantially Equivalent on May 13, 2021. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Prevest Denpro Limited has at least 6 other 510(k) clearances on record.