510(k) K213244

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) by Prevest Denpro Limited — Product Code ELW

K213244 is an FDA 510(k) premarket notification submitted by Prevest Denpro Limited for the device "Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)". The FDA issued a decision of Substantially Equivalent on September 9, 2022. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Prevest Denpro Limited has at least 6 other 510(k) clearances on record.