Cleared Traditional

K062961 - MICROLUX TRANSILLUMINATOR
(FDA 510(k) Clearance)

K062961 · Addent, Inc. · Dental
Feb 2007
Decision
132d
Days
Class 2
Risk

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

Submitted by Addent, Inc. (Danbury, US). The FDA issued a Cleared decision on February 8, 2007, 132 days after receiving the submission on September 29, 2006.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K062961 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NTK — Caries Detector, Laser Light, Transmission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1745