Cleared Traditional

K113655 - TI-MAX X TURBINE (FDA 510(k) Clearance)

K113655 · Nakanishi, Inc. · Dental device

Mar 2012

Decision

84d

Days

Class 1

Risk

K113655 is an FDA 510(k) clearance for the TI-MAX X TURBINE. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).

Submitted by Nakanishi, Inc. (Richardson, US). The FDA issued a Cleared decision on March 5, 2012, 84 days after receiving the submission on December 12, 2011.

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

Submission Details

510(k) Number	K113655 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 12, 2011
Decision Date	March 05, 2012
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF