Cleared Traditional

K062961 - MICROLUX TRANSILLUMINATOR

K062961 is an FDA 510(k) clearance for MICROLUX TRANSILLUMINATOR, manufactured by Addent, Inc.. The device is a Class 2 Dental device with product code NTK cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K062961 · Addent, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
132d
Days
Class 2
Risk

K062961 is an FDA 510(k) clearance for the MICROLUX TRANSILLUMINATOR. Classified as Caries Detector, Laser Light, Transmission (product code NTK), Class II - Special Controls.

Submitted by Addent, Inc. (Danbury, US). The FDA issued a Cleared decision on February 8, 2007 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1745 - 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 - K062961

510(k) Number K062961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date February 08, 2007
Days to Decision 132 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 128d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NTK Device Classification - Class 2, Special Controls

Product Code NTK Caries Detector, Laser Light, Transmission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1745
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NTK Caries Detector, Laser Light, Transmission

All 11
Devices cleared under the same product code (NTK) and FDA review panel - the closest regulatory comparables to K062961.
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