Cleared Traditional

K060335 - FILE-EZE

K060335 · Ultradent Products, Inc. · Dental device

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Feb 2006

Decision

15d

Days

Risk

K060335 is an FDA 510(k) clearance for the FILE-EZE. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 24, 2006 after a review of 15 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number	K060335 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 09, 2006
Decision Date	February 24, 2006
Days to Decision	15 days
Submission Type	Traditional
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

112d faster than avg

Panel avg: 127d · This submission: 15d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	KJJ Cleanser, Root Canal
Device Class	-

Regulatory Peers - KJJ Cleanser, Root Canal

All 17

Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K060335.

Straumann PrefGel

K162311 · Institut Straumann AG · Mar 2017

STRAUMANN PREFGEL

K063812 · Straumann USA · Jan 2007

CITRIC ACID 20% SOLUTION, MODEL 329

K063703 · Ultradent Products, Inc. · Dec 2006

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K060335

Ultradent Products, Inc.

South Jordan, UT · US

TAMMY LAVERY

Regulatory profile

104 submissions 104 cleared

100% clearance rate · Active in Dental

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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