# K983731: Pall Dental Filtration System with Inline Handpiece Housing and Filter Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Pall Medical
- Decided: Dec 21, 1998 after 60 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
Pall Medical’s Dental Unit Waterline Filtration system safely and effectively reduces bacteriological contaminants and endotoxins, and waterborne particulate matter from dental waterlines. The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retrofit existing dental waterlines.

Source page: https://510kreport.com/device/K983731
Methodology: https://510kreport.com/methodology