Cleared Traditional

VERSALUX

K010133 · Centrix, Inc. · Dental
Apr 2001
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K010133 is an FDA 510(k) clearance for the VERSALUX, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on April 5, 2001, 78 days after receiving the submission on January 17, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K010133 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2001
Decision Date April 05, 2001
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBZ — Activator, Ultraviolet, For Polymerization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6070

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