PERIO-FLOW nozzle— 510(k) K171174

Substantially Equivalent

E.M.S Electro Medical Systems S.A

FDA 510(k) clearance K171174 for PERIO-FLOW nozzle, Substantially Equivalent on 2017-12-18. Applicant: E.M.S Electro Medical Systems S.A.

Clearance details

Applicant: E.M.S Electro Medical Systems S.A
Product code: Code EFB
Advisory panel: Dental
Date received: 2017-04-21
Decision date: 2017-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nyon, CH

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.