510(k) K113376— NEOSS PROACTIVE TAPERED IMPLANT

Substantially Equivalent

Neoss, Ltd.

Clearance details

Applicant: Neoss, Ltd.
Product code: Code DZE
Advisory panel: Dental
Date received: 2011-11-16
Decision date: 2012-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, US

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.