# K032757: A-Dec Self-Contained Water System, Model 0.7 Liter Bottle & 2 Liter Bottle

- Pathway: 510(k) (Traditional)
- Applicant: A-Dec, Inc.
- Decided: Dec 10, 2003 after 96 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 A-dec Self-Contained Water System is intended for use in general dental applications by providing water to the dental syringe, various handpiece ancillary devices, and cuspidor cup-fill. The system allows for flushing and waterline maintenance to help prevent contamination and maintain clean dental unit waterlines.

Source page: https://510kreport.com/device/K032757
Methodology: https://510kreport.com/methodology