Cleared Traditional

K072309 - MICROLUX/BLU

K072309 is an FDA 510(k) clearance for MICROLUX/BLU, manufactured by Addent, Inc.. The device is a Class 1 Dental device with product code EAZ cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K072309 · Addent, Inc. · Dental device
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Nov 2007
Decision
94d
Days
Class 1
Risk

K072309 is an FDA 510(k) clearance for the MICROLUX/BLU. 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 November 19, 2007 after a review of 94 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.

FDA 510(k) Submission Details - K072309

510(k) Number K072309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2007
Decision Date November 19, 2007
Days to Decision 94 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
34d faster than avg
Panel avg: 128d · This submission: 94d
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 11
Devices cleared under the same product code (EAZ) and FDA review panel - the closest regulatory comparables to K072309.
MICROLUX DL
K041614 · Addent, Inc. · Apr 2005
VIZILITE-BLUE ORAL EXAM KIT
K033033 · Trylon Corp. · Nov 2004
SPECULITE/ORALLITE
K003995 · Trylon Corp. · Mar 2001
DENTAL LIGHT
K926081 · Mdt Corp., Inc. · Jan 1994
SIROLUX FANTASTIC
K935390 · Pelton & Crane Co. · Dec 1993
ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT
K925629 · Den-Tal-Ez Mfg Co., Inc. · Nov 1993