Cleared Traditional

R7

K130834 · Cefla S.C. · Dental
Oct 2013
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K130834 is an FDA 510(k) clearance for the R7, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Cefla S.C. (Ormond Beach, US). The FDA issued a Cleared decision on October 8, 2013, 196 days after receiving the submission on March 26, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K130834 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2013
Decision Date October 08, 2013
Days to Decision 196 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELC — Scaler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4850

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