Cleared Traditional

CARIES INDICATOR

K030807 · Confi-Dental Products Co. · Dental
Jun 2003
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K030807 is an FDA 510(k) clearance for the CARIES INDICATOR, a Device, Caries Detection (Class II — Special Controls, product code LFC), submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on June 9, 2003, 88 days after receiving the submission on March 13, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.1740.

Submission Details

510(k) Number K030807 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2003
Decision Date June 09, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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