Cleared Traditional

VALO Grand Corded and Accessory Lenses

K210550 · Ultradent Products, Inc. · Dental
Mar 2021
Decision
4d
Days
Class 2
Risk

About This 510(k) Submission

K210550 is an FDA 510(k) clearance for the VALO Grand Corded and Accessory Lenses, 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 March 1, 2021, 4 days after receiving the submission on February 25, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K210550 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2021
Decision Date March 01, 2021
Days to Decision 4 days
Submission Type Traditional
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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