Cleared Traditional

CARIES DETECTOR

K012733 · Kuraray Medical, Inc. · Dental
Sep 2001
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K012733 is an FDA 510(k) clearance for the CARIES DETECTOR, a Device, Caries Detection (Class II — Special Controls, product code LFC), submitted by Kuraray Medical, Inc. (New York, US). The FDA issued a Cleared decision on September 14, 2001, 31 days after receiving the submission on August 14, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.1740.

Submission Details

510(k) Number K012733 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2001
Decision Date September 14, 2001
Days to Decision 31 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

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