SP NEWTRON CAN-A +4 more— 510(k) K233922

Name: FDA 510(k) clearance K233922
Creator: U.S. Food and Drug Administration
Published: 2024-03-11

Substantially Equivalent

Satelec - Acteon Group

FDA 510(k) clearance K233922 for SP NEWTRON CAN-A +4 more, Substantially Equivalent on 2024-03-11. Applicant: Satelec - Acteon Group. Device class: 2.

Clearance details

Device name as filed: SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG
Applicant: Satelec - Acteon Group
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 2023-12-13
Decision date: 2024-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Merignac, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.