Cleared Traditional

Pac-Dent Denture Base Resin

K210189 · Pac-Dent, Inc. · Dental
Jul 2021
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K210189 is an FDA 510(k) clearance for the Pac-Dent Denture Base Resin, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on July 28, 2021, 184 days after receiving the submission on January 25, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K210189 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2021
Decision Date July 28, 2021
Days to Decision 184 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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