Cleared Traditional

AIR-FLOW PLUS Prophylaxis powder

K171189 · E.M.S Electro Medical Systems S.A · Dental
Sep 2017
Decision
140d
Days
Class 1
Risk

About This 510(k) Submission

K171189 is an FDA 510(k) clearance for the AIR-FLOW PLUS Prophylaxis powder, a Agent, Polishing, Abrasive, Oral Cavity (Class I — General Controls, product code EJR), submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on September 11, 2017, 140 days after receiving the submission on April 24, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.6030.

Submission Details

510(k) Number K171189 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2017
Decision Date September 11, 2017
Days to Decision 140 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJR — Agent, Polishing, Abrasive, Oral Cavity
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6030

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