Cleared Traditional

K003422 - EDTA ROOT CANAL CLEANSER

K003422 · Super Glide, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
77d
Days
-
Risk

K003422 is an FDA 510(k) clearance for the EDTA ROOT CANAL CLEANSER. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Super Glide, Inc. (Burlington, US). The FDA issued a Cleared decision on January 19, 2001 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Super Glide, Inc. devices

FDA 510(k) Submission Details - K003422

510(k) Number K003422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2000
Decision Date January 19, 2001
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 27
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K003422.
ENDOPURE ROOT CANAL CLEANSER
K032361 · Dentsply Intl. · Jan 2004
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
RCNG: ROOT CANAL NEGOTIATING GEL
K992484 · Jordco, Inc. · Oct 1999
PULPDENT SODIUM HYPOCHLORITE SOLUTION
K962743 · Pulpdent Corp. · Aug 1996