# K251869: Disposable Prophy Angle (3399-60, 3399-090, 3399-105)

- Pathway: 510(k) (Traditional)
- Applicant: Premium Plus (Dongguan) Limited
- Decided: Sep 15, 2025 after 89 days
- Product code: EGS (Handpiece, Contra- And Right-Angle Attachment, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K100854 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100854: Premium Plus Disposable Prophy Angle Model 3399, Premium Plus International Limited (2010) Summary page 5.

## Indications for use
Disposable Prophy Angle is intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. It is intended for single use, and should be discarded after each patient.

Source page: https://510kreport.com/device/K251869
Methodology: https://510kreport.com/methodology