510(k) · Cleared
ClearedDentapure DP 90 Cartridge, Dentapure DP 365 Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mrlb Intl., Inc. · EIA Unit, Operative Dental
Cleared on Sep 8, 1999 as substantially equivalent to K963548 (Mrlb Intl., Inc., 1997) after a 12-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Sep 8, 1999
- Review
- 12 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930144 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930144 The Scitech One-Day FilterScitech Solutions, Inc. · 1994
- 1 generation backK963548 Dentapure Dental Unit Water Line Filter-IodinatedMrlb Intl., Inc. · 1997
- This deviceK992893 Dentapure DP 90 Cartridge, Dentapure DP 365 CartridgeMrlb Intl., Inc. · 1999
- Descendant · cites it directly · 0 of its ownK232393 BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model…Proedge Dental Products, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232393BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180…Proedge Dental Products, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930144 | The Scitech One-Day Filter | Scitech Solutions, Inc. | 1994 | — |
| −1 | K963548 | Dentapure Dental Unit Water Line Filter-Iodinated | Mrlb Intl., Inc. | 1997 | — |
| 0 (this device) | K992893 | Dentapure DP 90 Cartridge, Dentapure DP 365 Cartridge | Mrlb Intl., Inc. | 1999 | — |
| +1 | K232393 | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers… | Proedge Dental Products, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 EIA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K963548 | Dentapure Dental Unit Water Line Filter-IodinatedSummary page 1…0 Cartridge; DentaPure® DP365 Cartridge Dental Unit Waterline Purification Cartridge Accessory for "Unit, Dental Operative" per CFR 872.6640) Class 1. DentaPure® DP1 (K963548) Manufactured by: MRLB International, Inc. 2450 College Way Fergus Falls, MN 56537 [per 807.92(a) (3)] The DentaPure® DP90 and D… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232393 | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180… | 2023 | 0 |
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 5 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K232393 (Proedge Dental Products, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K963548.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The DentaPure® DP90 and DP365 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992893 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992893: Dentapure DP 90 Cartridge, Dentapure DP 365 Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992893
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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