Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm— 510(k) K142667

Name: FDA 510(k) clearance K142667
Creator: U.S. Food and Drug Administration
Published: 2015-01-07

Substantially Equivalent

Sterngold Dental, LLC

FDA 510(k) clearance K142667 for Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm, Substantially Equivalent on 2015-01-07. Applicant: Sterngold Dental, LLC. Device class: 2.

Clearance details

Applicant: Sterngold Dental, LLC
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2014-09-19
Decision date: 2015-01-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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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.