Midwest Rhino XE and Air Motor M— 510(k) K192409

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K192409 for Midwest Rhino XE and Air Motor M, Substantially Equivalent on 2020-01-13. Applicant: Dentsply Sirona.

Clearance details

Applicant: Dentsply Sirona
Product code: Code EFB
Advisory panel: Dental
Date received: 2019-09-04
Decision date: 2020-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.