Cleared Traditional

K072309 - MICROLUX/BLU
(FDA 510(k) Clearance)

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

K072309 is an FDA 510(k) clearance for the MICROLUX/BLU. This device is classified as a Light, Operating, Dental (Class I — General Controls, product code EAZ).

Submitted by Addent, Inc. (Danbury, US). The FDA issued a Cleared decision on November 19, 2007, 94 days after receiving the submission on August 17, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4630.

Submission Details

510(k) Number K072309 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EAZ — Light, Operating, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4630