Cleared Traditional

EXPASYL POWER APPLICATOR

K051933 · Sybron Dental Specialties, Inc. · Dental
Jan 2006
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K051933 is an FDA 510(k) clearance for the EXPASYL POWER APPLICATOR, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on January 3, 2006, 174 days after receiving the submission on July 13, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K051933 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2005
Decision Date January 03, 2006
Days to Decision 174 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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