Cleared Traditional

L.E.DEMETRON

K021797 · Sybron Dental Specialties, Inc. · Dental
Jun 2002
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K021797 is an FDA 510(k) clearance for the L.E.DEMETRON, 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 June 27, 2002, 27 days after receiving the submission on May 31, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K021797 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2002
Decision Date June 27, 2002
Days to Decision 27 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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