Cleared Traditional

K150704 - PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer
(FDA 510(k) Clearance)

K150704 · Kuraray Noritake Dental, Inc. · Dental

Aug 2015

Decision

156d

Days

Class 2

Risk

K150704 is an FDA 510(k) clearance for the PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Kuraray Noritake Dental, Inc. (Chiyoda Ku, JP). The FDA issued a Cleared decision on August 21, 2015, 156 days after receiving the submission on March 18, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K150704 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2015
Decision Date	August 21, 2015
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF