Cleared Traditional

BESTALOY

K033434 · We Dong Myung Dental Industrial Co., Ltd. · Dental
Nov 2003
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K033434 is an FDA 510(k) clearance for the BESTALOY, a Alloy, Amalgam (Class II — Special Controls, product code EJJ), submitted by We Dong Myung Dental Industrial Co., Ltd. (Marietta, US). The FDA issued a Cleared decision on November 12, 2003, 15 days after receiving the submission on October 28, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3070.

Submission Details

510(k) Number K033434 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2003
Decision Date November 12, 2003
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJJ — Alloy, Amalgam
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3070