Cleared Traditional

ORALID

K123169 · Forward Science, LLC · Dental

Mar 2013

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K123169 is an FDA 510(k) clearance for the ORALID, a Diagnostic Light, Soft Tissue Detector (Class II — Special Controls, product code NXV), submitted by Forward Science, LLC (Sugar Land, US). The FDA issued a Cleared decision on March 13, 2013, 155 days after receiving the submission on October 9, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.6350.

Submission Details

510(k) Number	K123169 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2012
Decision Date	March 13, 2013
Days to Decision	155 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