OmniTaper EV Dental Implants, DS Implants abutments with EV connection— 510(k) K221094

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K221094 for OmniTaper EV Dental Implants, DS Implants abutments with EV connection, Substantially Equivalent on 2022-11-16. Applicant: Dentsply Sirona.

Clearance details

Applicant: Dentsply Sirona
Product code: Code DZE
Advisory panel: Dental
Date received: 2022-04-14
Decision date: 2022-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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.