Cleared Abbreviated

ERA IMPLANT

K021045 · Sterngold · Dental
Jun 2002
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K021045 is an FDA 510(k) clearance for the ERA IMPLANT, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Sterngold (Attleboro, US). The FDA issued a Cleared decision on June 26, 2002, 86 days after receiving the submission on April 1, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K021045 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2002
Decision Date June 26, 2002
Days to Decision 86 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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