510(k) · Cleared
ClearedBluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proedge Dental Products, Inc. · QYJ Dental Waterline Treatment Cartridge
Cleared on Oct 27, 2023 as substantially equivalent to K992893 (Mrlb Intl., Inc., 1999) and 1 other predicate after a 79-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Oct 27, 2023
- Review
- 79 days
- Class
- Class I
- Product code
- QYJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930144 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK930144 The Scitech One-Day FilterScitech Solutions, Inc. · 1994
- 2 generations backK963548 Dentapure Dental Unit Water Line Filter-IodinatedMrlb Intl., Inc. · 1997
- 1 generation backK992868 Dentapure DP40 CartridgeMrlb Intl., Inc. · 1999
- This deviceK232393 BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model…Proedge Dental Products, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930144 | The Scitech One-Day Filter | Scitech Solutions, Inc. | 1994 | — |
| −2 | K963548 | Dentapure Dental Unit Water Line Filter-Iodinated | Mrlb Intl., Inc. | 1997 | — |
| −1 | K992868 | Dentapure DP40 Cartridge | Mrlb Intl., Inc. | 1999 | — |
| 0 (this device) | K232393 | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers… | Proedge Dental Products, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QYJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992893 | Dentapure DP 90 Cartridge, Dentapure DP 365 CartridgeSummary page 5…ccessory (21 CFR 872.6640) Regulatory Class: Class I Product Code: QYJ, EIA 5.4 Predicates Primary Predicate: DentaPure® DP90 Cartridge; DentaPure® DP365 Cartridge (K992893) Common or Usual Name: Dental Unit Waterline Treatment Cartridge and Dental Unit Purification Cartridge Classification Name: Dent… | 1999 |
| * | K992868 | Dentapure DP40 CartridgeSummary page 5…idge Classification Name: Dental operative unit accessory (21 CFR 872.6640) Regulatory Class: Class I Product Code: EIA Additional Predicate: DentaPure® DP40 Cartridge (K992868) Common or Usual Name: Dental Unit Waterline Purification Cartridge Classification Name: Dental operative unit accessory (21 CFR… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All QYJ devicesQYJ Dental Waterline Treatment Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QYJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QYJ
Too few QYJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QYJ
No recall names QYJ since 2007.
Adverse event reports per year · QYJ
No MAUDE report names QYJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232393: BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232393
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026