Cleared Traditional

K151852 - PacEndo Sodium Hyprochlorite

K151852 · Pac-Dent International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
126d
Days
-
Risk

K151852 is an FDA 510(k) clearance for the PacEndo Sodium Hyprochlorite. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Pac-Dent International, Inc. (Brea, US). The FDA issued a Cleared decision on November 10, 2015 after a review of 126 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 International, Inc. devices

FDA 510(k) Submission Details - K151852

510(k) Number K151852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2015
Decision Date November 10, 2015
Days to Decision 126 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 127d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

KJJ Device Classification - Class 0,

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

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