Cleared Special

VALO Grand Corded

K190627 · Ultradent Products, Inc. · Dental
Apr 2019
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K190627 is an FDA 510(k) clearance for the VALO Grand Corded, 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 29, 2019, 48 days after receiving the submission on March 12, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K190627 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2019
Decision Date April 29, 2019
Days to Decision 48 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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