# K980577: Princess Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Sodexco
- Decided: May 8, 1998 after 80 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- 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 Princess Syringe is an air and water spray syringe assembled as a dental handpiece. This device has only one intended use. It is intended to deliver either a stream of water or air to areas of the oral cavity during dental procedures.

Source page: https://510kreport.com/device/K980577
Methodology: https://510kreport.com/methodology