Cleared Traditional

Pac-Dent Ceramic Nanohybrid Resin

K210412 · Pac-Dent, Inc. · Dental
Jul 2021
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K210412 is an FDA 510(k) clearance for the Pac-Dent Ceramic Nanohybrid Resin, 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 July 26, 2021, 165 days after receiving the submission on February 11, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K210412 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2021
Decision Date July 26, 2021
Days to Decision 165 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