Cleared Traditional

BENCO SPHERICAL

K031658 · Southern Dental Industries, Inc. · Dental
Jul 2003
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K031658 is an FDA 510(k) clearance for the BENCO SPHERICAL, a Alloy, Amalgam (Class II — Special Controls, product code EJJ), submitted by Southern Dental Industries, Inc. (Bensenville, US). The FDA issued a Cleared decision on July 29, 2003, 62 days after receiving the submission on May 28, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3070.

Submission Details

510(k) Number K031658 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2003
Decision Date July 29, 2003
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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