Cleared Traditional

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

K251869 · Premium Plus (Dongguan) Limited · Dental

Sep 2025

Decision

89d

Days

Class 1

Risk

About This 510(k) Submission

K251869 is an FDA 510(k) clearance for the Disposable Prophy Angle (3399-60, 3399-090, 3399-105), a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Premium Plus (Dongguan) Limited (Dongguan, CN). The FDA issued a Cleared decision on September 15, 2025, 89 days after receiving the submission on June 18, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K251869 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2025
Decision Date	September 15, 2025
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF