Cleared Traditional

CENTURY MODEL 105C

K093341 · Sybron Dental Specialties, Inc. · Dental
Apr 2010
Decision
164d
Days
Class 1
Risk

About This 510(k) Submission

K093341 is an FDA 510(k) clearance for the CENTURY MODEL 105C, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on April 5, 2010, 164 days after receiving the submission on October 23, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K093341 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2009
Decision Date April 05, 2010
Days to Decision 164 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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