Cleared Traditional

K200330 - RC-Prime Root Canal Preparation Cream (FDA 510(k) Clearance)

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

K200330 is an FDA 510(k) clearance for the RC-Prime Root Canal Preparation Cream. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on July 6, 2020 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Pac-Dent, Inc. devices

Submission Details

510(k) Number K200330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 127d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -