510(k) · Cleared
ClearedDentapure Dental Unit Water Line Filter-Iodinated
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 Jan 22, 1997 as substantially equivalent to K930144 (Scitech Solutions, Inc., 1994) after a 139-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.
- Decided
- Jan 22, 1997
- Review
- 139 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930144 (1994). 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK930144 The Scitech One-Day FilterScitech Solutions, Inc. · 1994
- This deviceK963548 Dentapure Dental Unit Water Line Filter-IodinatedMrlb Intl., Inc. · 1997
- Descendant · cites it directly · 1 of its ownK992893 Dentapure DP 90 Cartridge, Dentapure DP 365 CartridgeMrlb Intl., Inc. · 1999
- Descendant · cites it directly · 1 of its ownK992868 Dentapure DP40 CartridgeMrlb Intl., Inc. · 1999
- Descendant · cites it directly · 1 of its ownK973996 Clearline Plus, Dental Waterline FilterScitech Solutions, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK232393 BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model…Proedge Dental Products, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK981171 Eradic-AllTheratechnologies, Inc. · 1998
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K992893Dentapure DP 90 Cartridge, Dentapure DP 365 CartridgeMrlb Intl., Inc. · 1999 · cites it directly1descendant
- K992868Dentapure DP40 CartridgeMrlb Intl., Inc. · 1999 · cites it directly1descendant
- K973996Clearline Plus, Dental Waterline FilterScitech Solutions, Inc. · 1998 · cites it directly1descendant
- K232393BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180…Proedge Dental Products, Inc. · 2023 · 2 generations on0descendants
- K981171Eradic-AllTheratechnologies, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930144 | The Scitech One-Day Filter | Scitech Solutions, Inc. | 1994 | — |
| 0 (this device) | K963548 | Dentapure Dental Unit Water Line Filter-Iodinated | Mrlb Intl., Inc. | 1997 | — |
| +1 | K992893 | Dentapure DP 90 Cartridge, Dentapure DP 365 Cartridge | Mrlb Intl., Inc. | 1999 | — |
| +1 | K992868 | Dentapure DP40 Cartridge | Mrlb Intl., Inc. | 1999 | — |
| +1 | K973996 | Clearline Plus, Dental Waterline Filter | Scitech Solutions, Inc. | 1998 | — |
| +2 | K232393 | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers… | Proedge Dental Products, Inc. | 2023 | — |
| +1 | K981171 | Eradic-All | Theratechnologies, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K930144 | The Scitech One-Day FilterSummary page 1…dge Common Name: Inline Water Filter Classification Name: Accessory for "Unit, Dental Operative" per CFR 872.6640) Class I ‘ Equivalent Device: Clearline™ Cartridge, (K930144) Manufactured by: Device Description SciTech Dental 562 First Avenue South, Suite 700 Seattle, Washington 98104 [per 807.92(a… | 1994 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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™ Cartridge is an in-line filter assembly incorporating iodinated resin and is connected within 5" of the connection to the handpiece.
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/K963548 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963548: Dentapure Dental Unit Water Line Filter-Iodinated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963548
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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