Cleared Traditional

K091065 - AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 (FDA 510(k) Clearance)

K091065 · J. Morita USA, Inc. · Dental device

Oct 2009

Decision

185d

Days

Class 1

Risk

K091065 is an FDA 510(k) clearance for the AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on October 16, 2009, 185 days after receiving the submission on April 14, 2009.

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

Submission Details

510(k) Number	K091065 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 14, 2009
Decision Date	October 16, 2009
Days to Decision	185 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF