Cleared Abbreviated

STERNGOLD 66, MODEL #1180230

K021367 · Sterngold · Dental
May 2002
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K021367 is an FDA 510(k) clearance for the STERNGOLD 66, MODEL #1180230, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Sterngold (Attleboro, US). The FDA issued a Cleared decision on May 16, 2002, 16 days after receiving the submission on April 30, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K021367 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2002
Decision Date May 16, 2002
Days to Decision 16 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJS — Alloy, Other Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060