Cleared Traditional

K092289 - EMS AIR-FLOW HANDY PERIO (FDA 510(k) Clearance)

K092289 · E.M.S Electro Medical Systems S.A · Dental device

Oct 2009

Decision

83d

Days

Class 1

Risk

K092289 is an FDA 510(k) clearance for the EMS AIR-FLOW HANDY PERIO. 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 October 20, 2009, 83 days after receiving the submission on July 29, 2009.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K092289 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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