# K990844: Stardental Axcs Sterile Water System

- Pathway: 510(k) (Traditional)
- Applicant: Dentalez Group
- Decided: May 28, 1999 after 74 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. The FDA summary names its predicate without a number.
- (no number) SteriWater: named in the summary without a submission number
- (no number) AquaSept: named in the summary without a submission number
- (no number) Surgic IT: named in the summary without a submission number
- (no number) Suprasson P Max: named in the summary without a submission number
- (no number) Suni: named in the summary without a submission number
- (no number) other water delivery systems currently being marketed by Baxter and Abbott Labs: named in the summary without a submission number

## Indications for use
The Air Controlled Sterile Irrigation System is used by dental professionals for delivery of sterile water for oral surgical procedures, specifically for cooling a dental rotary instrument.

Source page: https://510kreport.com/device/K990844
Methodology: https://510kreport.com/methodology