Cleared Traditional

K133211 - ZIRTOUGH
(FDA 510(k) Clearance)

K133211 · Kuraray Noritake Dental, Inc. · Dental

Mar 2014

Decision

153d

Days

Class 2

Risk

K133211 is an FDA 510(k) clearance for the ZIRTOUGH. This device is classified as a Powder, Porcelain (Class II — Special Controls, product code EIH).

Submitted by Kuraray Noritake Dental, Inc. (Washington, US). The FDA issued a Cleared decision on March 20, 2014, 153 days after receiving the submission on October 18, 2013.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K133211 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2013
Decision Date	March 20, 2014
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement