Cleared Traditional

K082791 - EMS AIR-FLOW MASTER (FDA 510(k) Clearance)

K082791 · E.M.S Electro Medical Systems S.A · Dental device

Feb 2009

Decision

148d

Days

Class 1

Risk

K082791 is an FDA 510(k) clearance for the EMS AIR-FLOW MASTER. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K082791 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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