PROANGLE DISPOSABLE PROPHY ANGLE— 510(k) K030603

Substantially Equivalent

Pac-Dent International (Suzhou), Ltd.

FDA 510(k) clearance K030603 for PROANGLE DISPOSABLE PROPHY ANGLE, Substantially Equivalent on 2003-04-14. Applicant: Pac-Dent International (Suzhou), Ltd..

Clearance details

Applicant: Pac-Dent International (Suzhou), Ltd.
Product code: Code EGS
Advisory panel: Dental
Date received: 2003-02-25
Decision date: 2003-04-14
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, 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.