Cleared Traditional

K032361 - ENDOPURE ROOT CANAL CLEANSER (FDA 510(k) Clearance)

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

Submission Details

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
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 127d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -