Cleared Traditional

EMS AIR-FLOW HANDY PERIO

K092289 · E.M.S Electro Medical Systems S.A · Dental
Oct 2009
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K092289 is an FDA 510(k) clearance for the EMS AIR-FLOW HANDY PERIO, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by E.M.S Electro Medical Systems S.A (North Attleboro, US). The FDA issued a Cleared decision on October 20, 2009, 83 days after receiving the submission on July 29, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K092289 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2009
Decision Date October 20, 2009
Days to Decision 83 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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