Cleared Traditional

Evoblock, Perl?on

K243621 · Evoden Ind?stria Com?rcio Importa??o E Exporta??o · Dental
Apr 2025
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K243621 is an FDA 510(k) clearance for the Evoblock, Perl?on, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Evoden Ind?stria Com?rcio Importa??o E Exporta??o (Pirassununga, BR). The FDA issued a Cleared decision on April 22, 2025, 151 days after receiving the submission on November 22, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K243621 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2024
Decision Date April 22, 2025
Days to Decision 151 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770