Cleared Traditional

BIO 60

K041378 · Kodent, Inc. · Dental

Aug 2004

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K041378 is an FDA 510(k) clearance for the BIO 60, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Kodent, Inc. (Anaheim, US). The FDA issued a Cleared decision on August 2, 2004, 70 days after receiving the submission on May 24, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number	K041378 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2004
Decision Date	August 02, 2004
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF