Disposable Prophy Angle— 510(k) K240950

Substantially Equivalent

Pacific Care Limited

FDA 510(k) clearance K240950 for Disposable Prophy Angle, Substantially Equivalent on 2025-05-28. Applicant: Pacific Care Limited.

Clearance details

Applicant: Pacific Care Limited
Product code: Code EGS
Advisory panel: Dental
Date received: 2024-04-08
Decision date: 2025-05-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: N.T., HK

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.