Cleared Traditional

PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)

K142625 · Kuraray Noritake Dental, Inc. · Dental

Jan 2015

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K142625 is an FDA 510(k) clearance for the PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS), 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 January 27, 2015, 133 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	K142625 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2014
Decision Date	January 27, 2015
Days to Decision	133 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF