Cleared Traditional

K130834 - R7 (FDA 510(k) Clearance)

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

K130834 is an FDA 510(k) clearance for the R7. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K130834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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