# K963548: Dentapure Dental Unit Water Line Filter-Iodinated

- Pathway: 510(k) (Traditional)
- Applicant: Mrlb Intl., Inc.
- Decided: Jan 22, 1997 after 139 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
Longest line of descent: 1 generation back to K930144 (1994). 1 ancestor in all.
6 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930144: The Scitech One-Day Filter, Scitech Solutions, Inc. (1994) Summary page 1.

## Most influential descendants
- K992893: Dentapure DP 90 Cartridge, Dentapure DP 365 Cartridge (1999), 1 descendant of its own
- K992868: Dentapure DP40 Cartridge (1999), 1 descendant of its own
- K973996: Clearline Plus, Dental Waterline Filter (1998), 1 descendant of its own
- K232393: BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge (2023), 0 descendants of its own
- K981171: Eradic-All (1998), 0 descendants of its own

## Indications for use
The DentaPure™ Cartridge is an in-line filter assembly incorporating iodinated resin and is connected within 5" of the connection to the handpiece.

Source page: https://510kreport.com/device/K963548
Methodology: https://510kreport.com/methodology