Cleared Abbreviated

CRITERTION, MODEL #1067511

K021741 · Sterngold · Dental
Jun 2002
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K021741 is an FDA 510(k) clearance for the CRITERTION, MODEL #1067511, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Sterngold (Attleboro, US). The FDA issued a Cleared decision on June 26, 2002, 29 days after receiving the submission on May 28, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K021741 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2002
Decision Date June 26, 2002
Days to Decision 29 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJT — Alloy, Gold-based Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060

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