DeviceClearance

K132267

Substantially Equivalent

NEWTRON P5, NEWTRON P5 B.LED

Applicant
Satelec - Acteon Group
Product code
ELC
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mt. Laurel, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code ELC

product code ELC
Malfunction
1,255
Total
1,255

Source: openFDA MAUDE database, through . 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.