Cleared Special

K063703 - CITRIC ACID 20% SOLUTION

K063703 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
8d
Days
-
Risk

K063703 is an FDA 510(k) clearance for the CITRIC ACID 20% SOLUTION, MODEL 329. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 21, 2006 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ultradent Products, Inc. devices

Submission Details

510(k) Number K063703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2006
Decision Date December 21, 2006
Days to Decision 8 days
Submission Type Special
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
119d faster than avg
Panel avg: 127d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 17
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K063703.
ChlorCid, ChlorCid V, ChlorCid Surf
K173163 · Ultradent Products, Inc. · Feb 2018
Straumann PrefGel
K162311 · Institut Straumann AG · Mar 2017
STRAUMANN PREFGEL
K063812 · Straumann USA · Jan 2007
FILE-EZE
K060335 · Ultradent Products, Inc. · Feb 2006
ENDOPURE ROOT CANAL CLEANSER
K032361 · Dentsply Intl. · Jan 2004
ULTRADENT CITRIC ACID 10% SOLUTION
K032627 · Ultradent Products, Inc. · Nov 2003