MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm— 510(k) K171728

Substantially Equivalent

Sterngold Dental, LLC

FDA 510(k) clearance K171728 for MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm, Substantially Equivalent on 2017-09-28. Applicant: Sterngold Dental, LLC.

Clearance details

Applicant: Sterngold Dental, LLC
Product code: Code DZE
Advisory panel: Dental
Date received: 2017-06-12
Decision date: 2017-09-28
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.