Cleared Traditional

K131534 - KATANA ZIRCONIA
(FDA 510(k) Clearance)

K131534 · Kuraray Noritake Dental, Inc. · Dental

Oct 2013

Decision

135d

Days

Class 2

Risk

K131534 is an FDA 510(k) clearance for the KATANA ZIRCONIA. 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 October 11, 2013, 135 days after receiving the submission on May 29, 2013.

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

Submission Details

510(k) Number	K131534 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 2013
Decision Date	October 11, 2013
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement