iPhysio® System— 510(k) K232383

Name: FDA 510(k) clearance K232383
Creator: U.S. Food and Drug Administration
Published: 2025-03-04

Substantially Equivalent

Euroteknika

FDA 510(k) clearance K232383 for iPhysio® System, Substantially Equivalent on 2025-03-04. Applicant: Euroteknika. Device class: 2.

Clearance details

Applicant: Euroteknika
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2023-08-08
Decision date: 2025-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sallanches, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.