Cleared Special

VALO CORDLESS

K110582 · Ultradent Products, Inc. · Dental
Apr 2011
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K110582 is an FDA 510(k) clearance for the VALO CORDLESS, 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 April 28, 2011, 58 days after receiving the submission on March 1, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K110582 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2011
Decision Date April 28, 2011
Days to Decision 58 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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