Cleared Traditional

PERIO-FLOW nozzle

K171174 · E.M.S Electro Medical Systems S.A · Dental
Dec 2017
Decision
241d
Days
Class 1
Risk

About This 510(k) Submission

K171174 is an FDA 510(k) clearance for the PERIO-FLOW nozzle, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on December 18, 2017, 241 days after receiving the submission on April 21, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K171174 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2017
Decision Date December 18, 2017
Days to Decision 241 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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