Cleared Abbreviated

STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM

K023580 · Sterngold · Dental
Jan 2003
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K023580 is an FDA 510(k) clearance for the STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Sterngold (Ayer, US). The FDA issued a Cleared decision on January 17, 2003, 85 days after receiving the submission on October 24, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K023580 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2002
Decision Date January 17, 2003
Days to Decision 85 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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