Cleared Special

VALO, MODEL 5919

K083647 · Ultradent Products, Inc. · Dental
Jan 2009
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K083647 is an FDA 510(k) clearance for the VALO, MODEL 5919, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 23, 2009, 45 days after receiving the submission on December 9, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K083647 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2008
Decision Date January 23, 2009
Days to Decision 45 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

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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