MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System— 510(k) K251647

Substantially Equivalent

Dentsply Sirona, Inc.

FDA 510(k) clearance K251647 for MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System, Substantially Equivalent on 2025-08-21. Applicant: Dentsply Sirona, Inc..

Clearance details

Applicant: Dentsply Sirona, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2025-05-29
Decision date: 2025-08-21
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.