STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM— 510(k) K041271

Name: FDA 510(k) clearance K041271
Creator: U.S. Food and Drug Administration
Published: 2004-10-28

Substantially Equivalent

Sterngold

FDA 510(k) clearance K041271 for STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2004-10-28. Applicant: Sterngold. Device class: 2.

Clearance details

Applicant: Sterngold
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2004-05-12
Decision date: 2004-10-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ayer, MA, US

Download summary PDF View on FDA.gov ↗

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K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

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K092434 — STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM2009-11-10
K023580 — STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM2003-01-17
K022252 — STERNGOLD 1, MODEL 11277812002-09-19
K021045 — ERA IMPLANT2002-06-26
K021741 — CRITERTION, MODEL #10675112002-06-26

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.