Cleared Traditional

KERR VPS IMPRESSION MATERIAL

K050604 · Sybron Dental Specialties, Inc. · Dental
Apr 2005
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K050604 is an FDA 510(k) clearance for the KERR VPS IMPRESSION MATERIAL, 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 April 15, 2005, 37 days after receiving the submission on March 9, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K050604 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2005
Decision Date April 15, 2005
Days to Decision 37 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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