Cleared Traditional

K160577 - PacEndo Chlorhexidine

K160577 · Pac-Dent International, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
146d
Days
-
Risk

K160577 is an FDA 510(k) clearance for the PacEndo Chlorhexidine. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Pac-Dent International, Inc. (Brea, US). The FDA issued a Cleared decision on July 25, 2016 after a review of 146 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.

FDA 510(k) Submission Details - K160577

510(k) Number K160577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date July 25, 2016
Days to Decision 146 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 128d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

KJJ Device Classification - Class 0,

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 36
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K160577.
RC-Prime Root Canal Preparation Cream
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K162311 · Institut Straumann AG · Mar 2017
PacEndo EDTA
K153528 · Pac-Dent International, Inc. · Feb 2016
PacEndo Sodium Hyprochlorite
K151852 · Pac-Dent International, Inc. · Nov 2015
Irritrol, EDS Combo-Rinse
K150020 · Essential Dental Systesm, Inc. · Feb 2015