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

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.

Clearance details

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

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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.