# K100854: Premium Plus Disposable Prophy Angle Model 3399

- Pathway: 510(k) (Traditional)
- Applicant: Premium Plus International Limited
- Decided: Dec 9, 2010 after 258 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K251869: Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (2025), 0 descendants of its own

## Indications for use
The Premium Plus Disposable Prophy Angle Model 3399 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. The Premium Plus Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination. It is intended to be used for a single patient and should be discarded after each patient.

Source page: https://510kreport.com/device/K100854
Methodology: https://510kreport.com/methodology