Cleared Traditional

D/SENSE 1-STEP

K021146 · Centrix, Inc. · Dental
Jul 2002
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K021146 is an FDA 510(k) clearance for the D/SENSE 1-STEP, a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on July 2, 2002, 84 days after receiving the submission on April 9, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K021146 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2002
Decision Date July 02, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJK — Liner, Cavity, Calcium Hydroxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3250

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