# K220346: Lotus Prophy Angle

- Pathway: 510(k) (Traditional)
- Applicant: Ajk Engineering, Inc.
- Decided: Nov 7, 2022 after 273 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 K030603 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030603: Proangle Disposable Prophy Angle, Pac-Dent International (Suzhou), Ltd. (2003) Summary page 5.

## Most influential descendants
- K240950: Disposable Prophy Angle (2025), 0 descendants of its own

## Indications for use
The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.

Source page: https://510kreport.com/device/K220346
Methodology: https://510kreport.com/methodology