Cleared Special

K073284 - AIR-FLOW MASTER STANDARD
(FDA 510(k) Clearance)

K073284 · (Ems Sa) Electro Medical Systems · Dental
Dec 2007
Decision
23d
Days
Class 1
Risk

K073284 is an FDA 510(k) clearance for the AIR-FLOW MASTER STANDARD, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by (Ems Sa) Electro Medical Systems (North Attleboro, US). The FDA issued a Cleared decision on December 14, 2007, 23 days after receiving the submission on November 21, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K073284 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2007
Decision Date December 14, 2007
Days to Decision 23 days
Submission Type Special
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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