Cleared Abbreviated

STERN'S S250 NORDAM

K092917 · Cefla S.C. · Dental
Jun 2010
Decision
275d
Days
Class 1
Risk

About This 510(k) Submission

K092917 is an FDA 510(k) clearance for the STERN'S S250 NORDAM, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Cefla S.C. (Ormond Beach, US). The FDA issued a Cleared decision on June 24, 2010, 275 days after receiving the submission on September 22, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K092917 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2009
Decision Date June 24, 2010
Days to Decision 275 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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