Cleared Traditional

K112024 - TI-MAX X450 (FDA 510(k) Clearance)

K112024 · Nakanishi, Inc. · Dental device

Jun 2012

Decision

341d

Days

Class 1

Risk

K112024 is an FDA 510(k) clearance for the TI-MAX X450. 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 June 20, 2012, 341 days after receiving the submission on July 15, 2011.

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

Submission Details

510(k) Number	K112024 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 15, 2011
Decision Date	June 20, 2012
Days to Decision	341 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF