Cleared Abbreviated

APOLLO, MODEL 1124525

K020949 · Sterngold · Dental
Apr 2002
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K020949 is an FDA 510(k) clearance for the APOLLO, MODEL 1124525, 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 April 4, 2002, 10 days after receiving the submission on March 25, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K020949 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2002
Decision Date April 04, 2002
Days to Decision 10 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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