Cleared Traditional

K061701 - HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)
(FDA 510(k) Clearance)

K061701 · J. Morita USA, Inc. · Dental device

Aug 2006

Decision

70d

Days

Class 1

Risk

K061701 is an FDA 510(k) clearance for the HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H). This device is classified as a Handpiece, Belt And/or Gear Driven, Dental (Class I - General Controls, product code EFA).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on August 25, 2006, 70 days after receiving the submission on June 16, 2006.

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

Submission Details

510(k) Number	K061701 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 16, 2006
Decision Date	August 25, 2006
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF