Cleared Traditional

S200, S300

K133412 · Cefla S.C. · Dental
Jan 2015
Decision
427d
Days
Class 1
Risk

About This 510(k) Submission

K133412 is an FDA 510(k) clearance for the S200, S300, 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 January 8, 2015, 427 days after receiving the submission on November 7, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K133412 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2013
Decision Date January 08, 2015
Days to Decision 427 days
Submission Type Traditional
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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