SIMPLANT Online Case Review and SIMPLANT Editor— 510(k) K161118

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K161118 for SIMPLANT Online Case Review and SIMPLANT Editor, Substantially Equivalent on 2016-07-28. Applicant: Dentsply Sirona.

Clearance details

Applicant: Dentsply Sirona
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-04-20
Decision date: 2016-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.