Cleared Traditional

K041614 - MICROLUX DL (FDA 510(k) Clearance)

Class I Dental device.

K041614 · Addent, Inc. · Dental device
Apr 2005
Decision
293d
Days
Class 1
Risk

K041614 is an FDA 510(k) clearance for the MICROLUX DL. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Addent, Inc. (Danbury, US). The FDA issued a Cleared decision on April 4, 2005 after a review of 293 days - an extended review cycle.

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.

Submission Details

510(k) Number K041614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2004
Decision Date April 04, 2005
Days to Decision 293 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 158d · This submission: 293d
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.