Cleared Traditional

MICROLUX/DL MICROLUX/BLU BIO/SCREEN

K121282 · Addent, Inc. · Dental
Jul 2012
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K121282 is an FDA 510(k) clearance for the MICROLUX/DL MICROLUX/BLU BIO/SCREEN, a Diagnostic Light, Soft Tissue Detector (Class II — Special Controls, product code NXV), submitted by Addent, Inc. (Danbury, US). The FDA issued a Cleared decision on July 24, 2012, 85 days after receiving the submission on April 30, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.6350.

Submission Details

510(k) Number K121282 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2012
Decision Date July 24, 2012
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code NXV — Diagnostic Light, Soft Tissue Detector
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6350
Definition To Be Used As An Aid In The Detection Or Visualization Of Abnormalities Of Intraoral Soft Tissue. An Adjunct To Traditional Intraoral Examination By Incandescent Light To Enhance The Visualization Of Oral Mucosal Abnormalities