Cleared Traditional

OptiComp

K202920 · Pac-Dent, Inc. · Dental
May 2022
Decision
603d
Days
Class 2
Risk

About This 510(k) Submission

K202920 is an FDA 510(k) clearance for the OptiComp, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on May 25, 2022, 603 days after receiving the submission on September 29, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K202920 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2020
Decision Date May 25, 2022
Days to Decision 603 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690