510(k) K132267— NEWTRON P5, NEWTRON P5 B.LED

Substantially Equivalent

Satelec - Acteon Group

Clearance details

Applicant: Satelec - Acteon Group
Product code: Code ELC
Advisory panel: Dental
Date received: 2013-07-22
Decision date: 2014-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Laurel, NJ, US

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.