Cleared Traditional

K902685 - DEFIANCE MODEL FUS 336

K902685 is an FDA 510(k) clearance for DEFIANCE MODEL FUS 336, manufactured by Defiance Electronics, Inc.. The device is a Class 1 Dental device with product code EAZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K902685 · Defiance Electronics, Inc. · Dental device
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Sep 1990
Decision
90d
Days
Class 1
Risk

K902685 is an FDA 510(k) clearance for the DEFIANCE MODEL FUS 336. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Defiance Electronics, Inc. (Lenoir City, US). The FDA issued a Cleared decision on September 17, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - the FDA dental device regulatory framework. 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 Defiance Electronics, Inc. devices

FDA 510(k) Submission Details - K902685

510(k) Number K902685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1990
Decision Date September 17, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EAZ Device Classification - Class 1, General Controls

Product Code EAZ Light, Operating, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EAZ Light, Operating, Dental

All 7
Devices cleared under the same product code (EAZ) and FDA review panel - the closest regulatory comparables to K902685.
MICROLUX/BLU
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K893044 · A-Dec, Inc. · Jul 1989
F-11 REFLECTOR / F-II STANDARD REFLECTOR
K863019 · Sds Dental, Inc. · Sep 1986
OPTI-BEAM IV
K832919 · Dentsply Intl. · Mar 1984