Cleared Traditional

VALO X, VALO X Accessory Lenses

K220471 · Ultradent Products, Inc. · Dental
Feb 2022
Decision
4d
Days
Class 2
Risk

About This 510(k) Submission

K220471 is an FDA 510(k) clearance for the VALO X, VALO X 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 February 22, 2022, 4 days after receiving the submission on February 18, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K220471 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2022
Decision Date February 22, 2022
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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