Cleared Traditional

Valiant Curing Light

K170101 · Inter-Med/Vista Dental Products · Dental
Jun 2017
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K170101 is an FDA 510(k) clearance for the Valiant Curing Light, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on June 8, 2017, 148 days after receiving the submission on January 11, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K170101 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2017
Decision Date June 08, 2017
Days to Decision 148 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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