Cleared Traditional

ISOLIGHT (K894059) - FDA 510(k) Clearance

Class I Dental device.

K894059 · Eurodent, Inc. · Dental device
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Sep 1989
Decision
92d
Days
Class 1
Risk

K894059 is an FDA 510(k) clearance for the ISOLIGHT. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Eurodent, Inc. (Canada J4b 5z5, CA). The FDA issued a Cleared decision on September 7, 1989 after a review of 92 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 Eurodent, Inc. devices

Submission Details

510(k) Number K894059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1989
Decision Date September 07, 1989
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.