Cleared Traditional

K934415 - FILE-EZE

K934415 · Ultradent Products, Inc. · Dental device

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Apr 1994

Decision

215d

Days

Risk

K934415 is an FDA 510(k) clearance for the FILE-EZE. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Ultradent Products, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on April 13, 1994 after a review of 215 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.

FDA 510(k) Submission Details - K934415

510(k) Number	K934415 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 10, 1993
Decision Date	April 13, 1994
Days to Decision	215 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

87d slower than avg

Panel avg: 128d · This submission: 215d

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 40

Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K934415.

RCNG: ROOT CANAL NEGOTIATING GEL

K992484 · Jordco, Inc. · Oct 1999

PULPDENT SODIUM HYPOCHLORITE SOLUTION

K962743 · Pulpdent Corp. · Aug 1996

MOYCO-EDTA

K950365 · Union Broach, Div. Moyco Industries, Inc. · Apr 1995

DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT

K921713 · A and V Ent. · Nov 1993

POINT, PAPER ENDODONTIC

K830814 · Endodent, Inc. · Apr 1983

CLEANSER, ROOT CANAL

K802853 · Dentsply Intl. · Dec 1980

FDA 510(k) Resources - Dental

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

Manufacturer of K934415

Ultradent Products, Inc.

Lake Oswego, OR · US

ARTHUR J SAFFIR

Regulatory profile

104 submissions 104 cleared

100% clearance rate · Active in Dental

View all devices by Ultradent Products, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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 . FDA decision: April 13, 1994. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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