Cleared Traditional

K043177 - CLEAFIL DC CORE AUTOMIX
(FDA 510(k) Clearance)

K043177 · Kuraray Medical, Inc. · Dental

Dec 2004

Decision

31d

Days

Class 2

Risk

K043177 is an FDA 510(k) clearance for the CLEAFIL DC CORE AUTOMIX. This device is classified as a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF).

Submitted by Kuraray Medical, Inc. (New York, US). The FDA issued a Cleared decision on December 17, 2004, 31 days after receiving the submission on November 16, 2004.

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

Submission Details

510(k) Number	K043177 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 16, 2004
Decision Date	December 17, 2004
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement