DeviceClearance

MIS CONNECT Conical Connection System— 510(k) K193078

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K193078 for MIS CONNECT Conical Connection System, Substantially Equivalent on 2020-03-25. Applicant: Dentsply Sirona.

Clearance details

Applicant
Dentsply Sirona
Product code
Code NHA
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
York, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code NHA

product code NHA
Injury
1,270
Malfunction
2,860
Total
4,130

Source: openFDA MAUDE database, through . 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.