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)

About This 510(k) Submission

K213244 is an FDA 510(k) clearance for the 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), a Material, Impression (Class II — Special Controls, product code ELW), submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on September 9, 2022, 344 days after receiving the submission on September 30, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.