Cleared Traditional

K132478 - AIR-FLOW HANDY 3.0 (FDA 510(k) Clearance)

K132478 · E.M.S Electro Medical Systems S.A · Dental device

Apr 2014

Decision

246d

Days

Class 1

Risk

K132478 is an FDA 510(k) clearance for the AIR-FLOW HANDY 3.0. 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 (Marlborough, US). The FDA issued a Cleared decision on April 11, 2014, 246 days after receiving the submission on August 8, 2013.

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

Submission Details

510(k) Number	K132478 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 08, 2013
Decision Date	April 11, 2014
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF