Cleared Traditional

RC-Prime Root Canal Preparation Cream

K200330 · Pac-Dent, Inc. · Dental
Jul 2020
Decision
147d
Days
—
Risk

About This 510(k) Submission

K200330 is an FDA 510(k) clearance for the RC-Prime Root Canal Preparation Cream, a Cleanser, Root Canal, submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on July 6, 2020, 147 days after receiving the submission on February 10, 2020. This device falls under the Dental review panel.

Submission Details

510(k) Number K200330 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2020
Decision Date July 06, 2020
Days to Decision 147 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KJJ — Cleanser, Root Canal
Device Class —