Cleared Traditional

DENTLIGHT ORAL EXAM LIGHT KIT

K101140 · Dentlight, Inc. · Dental
Jul 2010
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K101140 is an FDA 510(k) clearance for the DENTLIGHT ORAL EXAM LIGHT KIT, a Diagnostic Light, Soft Tissue Detector (Class II — Special Controls, product code NXV), submitted by Dentlight, Inc. (Richardson, US). The FDA issued a Cleared decision on July 15, 2010, 84 days after receiving the submission on April 22, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.6350.

Submission Details

510(k) Number K101140 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2010
Decision Date July 15, 2010
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

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