# K232393: BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Proedge Dental Products, Inc.
- Decided: Oct 27, 2023 after 79 days
- Product code: QYJ (Dental Waterline Treatment Cartridge)
- 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: 3 generations back to K930144 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992893: Dentapure DP 90 Cartridge, Dentapure DP 365 Cartridge, Mrlb Intl., Inc. (1999) Summary page 5.
- K992868: Dentapure DP40 Cartridge, Mrlb Intl., Inc. (1999) Summary page 5.

## Indications for use
The BluTube® Dental Unit Water Purification Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way airwater 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 to the instruments to less than 200 CFU/mL, a level that will meet or exceed the current American Dental Association (ADA) recommendations for water quality.

Source page: https://510kreport.com/device/K232393
Methodology: https://510kreport.com/methodology