Medical Device Manufacturer · CN , Dongguan

Premium Plus (Dongguan) Limited - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2022

Recent clearances: Disposable Prophy Angle (3399-60, 3399-090, 3399-105), LED Curing Light (C01-X, C02-X), Disposable Barrier Sleeves

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Premium Plus (Dongguan) Limited Dental ✕

3 devices

1-3 of 3

Cleared Sep 15, 2025

Disposable Prophy Angle (3399-60, 3399-090, 3399-105)

Cleared Apr 10, 2025

LED Curing Light (C01-X, C02-X)

Cleared May 11, 2022

Disposable Barrier Sleeves