Cleared Traditional

TEAM CARIES INDICATOR

K963927 · Centrix, Inc. · Dental
Nov 1996
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K963927 is an FDA 510(k) clearance for the TEAM CARIES INDICATOR, a Device, Caries Detection (Class II — Special Controls, product code LFC), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on November 15, 1996, 66 days after receiving the submission on September 10, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.1740.

Submission Details

510(k) Number K963927 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 1996
Decision Date November 15, 1996
Days to Decision 66 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