# K992868: Dentapure DP40 Cartridge

- Pathway: 510(k) (Special)
- Applicant: Mrlb Intl., Inc.
- Decided: Sep 7, 1999 after 12 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: 2 generations back to K930144 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963548: Dentapure Dental Unit Water Line Filter-Iodinated, Mrlb Intl., Inc. (1997) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The DentaPure® DP40 Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way air/water syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied through the instruments to a level that will meet or exceed the current ADA recommendations for water quality having a maximum of 200 cfu/ml.

Source page: https://510kreport.com/device/K992868
Methodology: https://510kreport.com/methodology