Disposable Prophy Angle (3399-60, 3399-090, 3399-105)— 510(k) K251869

Name: FDA 510(k) clearance K251869
Creator: U.S. Food and Drug Administration
Published: 2025-09-15

Substantially Equivalent

Premium Plus (Dongguan) Limited

FDA 510(k) clearance K251869 for Disposable Prophy Angle (3399-60, 3399-090, 3399-105), Substantially Equivalent on 2025-09-15. Applicant: Premium Plus (Dongguan) Limited. Device class: 1.

Clearance details

Applicant: Premium Plus (Dongguan) Limited
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2025-06-18
Decision date: 2025-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EGS

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K240950 — Disposable Prophy Angle2025-05-28
K240183 — Star E900 Handpiece Series2024-09-19
K230106 — General Cutting Straight2023-05-24
K222518 — FX Contra2022-11-17
K220346 — Lotus Prophy Angle2022-11-07

More clearances from Premium Plus (Dongguan) Limited

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K250009 — LED Curing Light (C01-X, C02-X)2025-04-10
K220662 — Disposable Barrier Sleeves2022-05-11

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.