Disposable Prophy Angle— 510(k) K240950

Name: FDA 510(k) clearance K240950
Creator: U.S. Food and Drug Administration
Published: 2025-05-28

Substantially Equivalent

Pacific Care Limited

FDA 510(k) clearance K240950 for Disposable Prophy Angle, Substantially Equivalent on 2025-05-28. Applicant: Pacific Care Limited. Device class: 1.

Clearance details

Applicant: Pacific Care Limited
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
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 ↗

Recent devices under product code EGS

view all

K251869 — Disposable Prophy Angle (3399-60, 3399-090, 3399-105)2025-09-15
K240183 — Star E900 Handpiece Series2024-09-19
K230106 — General Cutting Straight2023-05-24
K222518 — FX Contra2022-11-17
K220346 — Lotus Prophy Angle2022-11-07

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.