510(k) · Cleared
ClearedClearline Plus, Dental Waterline Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scitech Solutions, Inc. · EIA Unit, Operative Dental
Cleared on Feb 4, 1998 as substantially equivalent to K963548 (Mrlb Intl., Inc., 1997) and 2 other predicates after a 106-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Feb 4, 1998
- Review
- 106 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K930144 (1994). 3 ancestors in all. 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 deviceK973996 Clearline Plus, Dental Waterline FilterScitech Solutions, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK982009 One Week Backstop Dental Anti-Retraction Check ValveScitech Solutions, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K982009One Week Backstop Dental Anti-Retraction Check ValveScitech Solutions, Inc. · 1998 · 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) | K973996 | Clearline Plus, Dental Waterline Filter | Scitech Solutions, Inc. | 1998 | — |
| +1 | K982009 | One Week Backstop Dental Anti-Retraction Check Valve | Scitech Solutions, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (3)
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 7…kback”) of patient-derived microorganisms into a dental line, even when there is negative pressure applied upstream. These claims are equivalent to those for Dentapure (K 963548), where it is stated that the device will “commonly reduce bacterial levels to less than one cfu/milliliter” downstream of the fi… | 1997 |
| * | K930144 | The Scitech One-Day FilterSummary page 1…Predicate device was on interstate market prior to 1976. Other comparable devices have received 510 (k) clearance since the Device Amendment SciTech’s one day filter (K.930144) was given regulatory clearance on December 3, 1993. SciTech’s anti-retraction check valve (K.960556) was given clearance on Feb… | 1994 |
| * | K960556 | Bacstop Dental Anti-Retraction Check ValveSummary page 1…k) clearance since the Device Amendment SciTech’s one day filter (K.930144) was given regulatory clearance on December 3, 1993. SciTech’s anti-retraction check valve (K.960556) was given clearance on February 9, 1996. MLRB International, Inc. received clearance for a similar device (K.963548) on January… | 1996 |
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 |
|---|---|---|---|
| K982009 | One Week Backstop Dental Anti-Retraction Check Valve | 1998 | 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 4 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K982009 (Scitech Solutions, Inc., 1998) 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?
CLEARLINE PLUS™ is a disposable, combined 0.22 micron filter and anti-retraction check valve for use in dental unit water lines. It is intended to be used, in line, as a means of controlling bacteriological contaminants in the dental water and preventing the retraction of orally contaminated fluids into the dental line. It is to be used for all patients and changed every week, or.5 working days. CLEARLINE PLUS™ is to be installed within the last several…
Read the full statement (147 words)
CLEARLINE PLUS™ is a disposable, combined 0.22 micron filter and anti-retraction
check valve for use in dental unit water lines. It is intended to be used, in line, as a means
of controlling bacteriological contaminants in the dental water and preventing the
retraction of orally contaminated fluids into the dental line. It is to be used for all patients
and changed every week, or.5 working days.
CLEARLINE PLUS™ is to be installed within the last several inches of tubing, before the
dental handpiece, air/water syringe or ultrasonic scaler. The filter comprises a 0.2 micron
bacterial retentive membrane to reduce bacteriological contaminants in the dental water.
The check valve opens only when sufficient pressure is applied (1.5 psi) and snaps closed
when the pressure drops below this point, thereby sealing the line against any backflow.
The device is inserted by connection to luer mounts placed permanently in line.
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/K973996 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973996: Clearline Plus, Dental Waterline Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973996
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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