Cleared Traditional

PANAVIA SA Cement Plus Handmix

K142623 · Kuraray Noritake Dental, Inc. · Dental
Feb 2015
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K142623 is an FDA 510(k) clearance for the PANAVIA SA Cement Plus Handmix, 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 February 26, 2015, 163 days after receiving the submission on September 16, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K142623 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2014
Decision Date February 26, 2015
Days to Decision 163 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275