# K023232: Splatrfree Swangle 360 Disposable Prophylaxis Angle

- Pathway: 510(k) (Traditional)
- Applicant: Smartpractice
- Decided: Dec 11, 2002 after 75 days
- Product code: EFS (Unit, Oral Irrigation)
- Device class: 1
- Regulation: 21 CFR 872.6510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The SplatrFree Swangle 360 Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient.

Source page: https://510kreport.com/device/K023232
Methodology: https://510kreport.com/methodology