Cleared Special

VALO Grand

K160551 · Ultradent Products, Inc. · Dental
Jul 2016
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K160551 is an FDA 510(k) clearance for the VALO Grand, 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 July 13, 2016, 135 days after receiving the submission on February 29, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K160551 FDA.gov
FDA Decision Cleared SESE
Date Received February 29, 2016
Decision Date July 13, 2016
Days to Decision 135 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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