Simplant Digital Guide— 510(k) K193405

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K193405 for Simplant Digital Guide, Substantially Equivalent on 2020-09-02. Applicant: Dentsply Sirona.

Clearance details

Applicant: Dentsply Sirona
Product code: Code NDP
Advisory panel: Dental
Date received: 2019-12-09
Decision date: 2020-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDP

product code NDP

Injury: 454
Malfunction: 1,956
Total: 2,410

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.