Cleared Special

BIOPURE MTAD ROOT CANAL CLEANSER (K053167) - FDA 510(k) Clearance

K053167 · Dentsply Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
24d
Days
-
Risk

K053167 is an FDA 510(k) clearance for the BIOPURE MTAD ROOT CANAL CLEANSER. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Dentsply Intl., Inc. (York, US). The FDA issued a Cleared decision on December 8, 2005 after a review of 24 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 Dentsply Intl., Inc. devices

Submission Details

510(k) Number K053167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date December 08, 2005
Days to Decision 24 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 127d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 11
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K053167.
RC-Prime Root Canal Preparation Cream
K200330 · Pac-Dent, Inc. · Jul 2020
ChlorCid, ChlorCid V, ChlorCid Surf
K173163 · Ultradent Products, Inc. · Feb 2018
Straumann PrefGel
K162311 · Institut Straumann AG · Mar 2017
ENDOPURE ROOT CANAL CLEANSER
K032361 · Dentsply Intl. · Jan 2004
CLEANSER, ROOT CANAL
K802853 · Dentsply Intl. · Dec 1980