Cleared Traditional

DISCOVRED

K102821 · Phoenix Dental, Inc. · Dental
Mar 2011
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K102821 is an FDA 510(k) clearance for the DISCOVRED, a Device, Caries Detection (Class II — Special Controls, product code LFC), submitted by Phoenix Dental, Inc. (Fenton, US). The FDA issued a Cleared decision on March 11, 2011, 164 days after receiving the submission on September 28, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.1740.

Submission Details

510(k) Number K102821 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2010
Decision Date March 11, 2011
Days to Decision 164 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFC — Device, Caries Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1740