K030603

Substantially Equivalent

PROANGLE DISPOSABLE PROPHY ANGLE

Applicant
Pac-Dent International (Suzhou), Ltd.
Product code
EGS
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Jiangsu Province, CN
Download summary PDF View on FDA.gov ↗

Adverse events under product code EGS

product code EGS
Injury
356
Malfunction
759
Total
1,115

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.