Cleared Traditional

K-ETCHANT SYRINGE; NEEDLE TIP (E)

K133078 · Kuraray Noritake Dental, Inc. · Dental
Dec 2013
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K133078 is an FDA 510(k) clearance for the K-ETCHANT SYRINGE; NEEDLE TIP (E), a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on December 20, 2013, 84 days after receiving the submission on September 27, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K133078 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2013
Decision Date December 20, 2013
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200