Cleared Traditional

BIO-SCREEN

K082668 · Addent, Inc. · Dental
Jan 2009
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K082668 is an FDA 510(k) clearance for the 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 January 23, 2009, 133 days after receiving the submission on September 12, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.6350.

Submission Details

510(k) Number K082668 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2008
Decision Date January 23, 2009
Days to Decision 133 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