Cleared Special

K063703 - CITRIC ACID 20% SOLUTION, MODEL 329

K063703 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K063703

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
120d faster than avg
Panel avg: 128d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

KJJ Device Classification - Class 0,

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 40
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K063703.
EDTA PLUS
K072555 · Essential Dental Systems, Inc. · Dec 2007
ENDO-CHX
K070401 · Essential Dental Systems, Inc. · Jul 2007
STRAUMANN PREFGEL
K063812 · Straumann USA · Jan 2007
AQUATINE EC ENDODONTIC CLEANSER
K061689 · Puricore, Inc. · Aug 2006
FILE-EZE
K060335 · Ultradent Products, Inc. · Feb 2006
BIOPURE MTAD ROOT CANAL CLEANSER
K053167 · Dentsply Intl., Inc. · Dec 2005
K063703 · CITRIC ACID 20% SOLUTION, MODEL 329
Download PDF FDA Summary Ultradent Products, I…