AIR-FLOW PLUS Prophylaxis powder— 510(k) K171189

Name: FDA 510(k) clearance K171189
Creator: U.S. Food and Drug Administration
Published: 2017-09-11

Substantially Equivalent

E.M.S Electro Medical Systems S.A

FDA 510(k) clearance K171189 for AIR-FLOW PLUS Prophylaxis powder, Substantially Equivalent on 2017-09-11. Applicant: E.M.S Electro Medical Systems S.A. Device class: 1.

Clearance details

Applicant: E.M.S Electro Medical Systems S.A
Product code: Code EJR
Device class: Class 1
Regulation: 21 CFR 872.6030
Advisory panel: Dental
Date received: 2017-04-24
Decision date: 2017-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nyon, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJR

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K131760 — WHIP MIX PREPPIES PLUS2014-03-26
K121698 — NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN2012-08-06
K103114 — OSSPRAY SYLC CR2011-03-14
K102053 — BUTLER CALCI-FLOR PROPHYLAXIS PASTE2011-02-03
K101104 — REMIN PRO2010-10-21

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K190124 — EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One2019-10-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.