Cleared Traditional

K043498 - TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE (FDA 510(k) Clearance)

K043498 · J. Morita USA, Inc. · Dental device

Feb 2005

Decision

61d

Days

Class 1

Risk

K043498 is an FDA 510(k) clearance for the TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE. 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 February 16, 2005, 61 days after receiving the submission on December 17, 2004.

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

Submission Details

510(k) Number	K043498 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 17, 2004
Decision Date	February 16, 2005
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF