Cleared Traditional

K153476 - KATANA AVENCIA Block
(FDA 510(k) Clearance)

K153476 · Kuraray Noritake Dental, Inc. · Dental
Aug 2016
Decision
265d
Days
Class 2
Risk

K153476 is an FDA 510(k) clearance for the KATANA AVENCIA Block. This device is classified as a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF).

Submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on August 23, 2016, 265 days after receiving the submission on December 2, 2015.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K153476 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2015
Decision Date August 23, 2016
Days to Decision 265 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690