Cleared Traditional

EMS AIR-FLOW MASTER

K082791 · E.M.S Electro Medical Systems S.A · Dental
Feb 2009
Decision
148d
Days
Class 1
Risk

About This 510(k) Submission

K082791 is an FDA 510(k) clearance for the EMS AIR-FLOW MASTER, 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 February 18, 2009, 148 days after receiving the submission on September 23, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K082791 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2008
Decision Date February 18, 2009
Days to Decision 148 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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