Cleared Traditional

OPTILUX CURING LIGHTS

K020267 · Sybron Dental Specialties, Inc. · Dental
Mar 2002
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K020267 is an FDA 510(k) clearance for the OPTILUX CURING LIGHTS, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on March 29, 2002, 63 days after receiving the submission on January 25, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K020267 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2002
Decision Date March 29, 2002
Days to Decision 63 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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