Cleared Traditional

CALCIJECT

K001050 · Centrix, Inc. · Dental
Jul 2000
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K001050 is an FDA 510(k) clearance for the CALCIJECT, 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 21, 2000, 112 days after receiving the submission on March 31, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K001050 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2000
Decision Date July 21, 2000
Days to Decision 112 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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