Cleared Traditional

STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS

K092951 · Mectron S.P.A. · Dental
Dec 2009
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K092951 is an FDA 510(k) clearance for the STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on December 7, 2009, 74 days after receiving the submission on September 24, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K092951 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2009
Decision Date December 07, 2009
Days to Decision 74 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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