Cleared Traditional

K032361 - ENDOPURE ROOT CANAL CLEANSER

K032361 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
165d
Days
-
Risk

K032361 is an FDA 510(k) clearance for the ENDOPURE ROOT CANAL CLEANSER. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on January 12, 2004 after a review of 165 days - an extended review cycle.

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 Dentsply Intl. devices

FDA 510(k) Submission Details - K032361

510(k) Number K032361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2003
Decision Date January 12, 2004
Days to Decision 165 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 127d · This submission: 165d
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 34
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K032361.
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
ULTRADENT CITRIC ACID 10% SOLUTION
K032627 · Ultradent Products, Inc. · Nov 2003
SMEARCLEAR
K024198 · Sybron Dental Specialties, Inc. · Mar 2003
OXY-GLIDE ROOT CANAL CLEANSER & LUB.
K992919 · Super Glide, Inc. · Nov 1999