510(k) · Cleared
ClearedOne Week Backstop Dental Anti-Retraction Check Valve
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 Jun 25, 1998 as substantially equivalent to K973996 (Scitech Solutions, Inc., 1998) and 1 other predicate after an 84-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jun 25, 1998
- Review
- 84 days
- Class
- Class I
- Product code
- EIA
- 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 backK973996 Clearline Plus, Dental Waterline FilterScitech Solutions, Inc. · 1998
- This deviceK982009 One Week Backstop Dental Anti-Retraction Check ValveScitech Solutions, Inc. · 1998
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 | K973996 | Clearline Plus, Dental Waterline Filter | Scitech Solutions, Inc. | 1998 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K973996 | Clearline Plus, Dental Waterline FilterSummary page 1…disposable in-line Anti-retraction check valve Classification Name of Device: Unknown Legally Marketéd Device to which BACSTOP™ VALVE is equivalent: Clearline® Plus (K973996) and BacStop™ valve - daily (K960556) from SciTech Dental, Inc., 562 1% Avenue South, Suite 700, Seattle, WA 98104. ' Descriptio… | 1998 |
| * | K960556 | Bacstop Dental Anti-Retraction Check ValveSummary page 1…heck valve Classification Name of Device: Unknown Legally Marketéd Device to which BACSTOP™ VALVE is equivalent: Clearline® Plus (K973996) and BacStop™ valve - daily (K960556) from SciTech Dental, Inc., 562 1% Avenue South, Suite 700, Seattle, WA 98104. ' Description of the Device: BacStop™ valve is a… | 1996 |
| † | K790062 | IV Administration Set with Backcheck | 1979 |
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 4 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- None of the 4 ancestors has a recall.
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 BACSTOP™ dental waterline Anti-retraction valve is normally closed disposable valve, which is replaced every week, or 5 working days. It is intended to be used in-line on dental unit water lines as a means of preventing the retraction of orally contaminated fluids into the coolant and irrigant water hoses. It is to be used for all patients. BACSTOP™ is to be installed within the last several inches of tubing, before the dental handpiece, air/water…
Read the full statement (116 words)
The BACSTOP™ dental waterline Anti-retraction valve is normally closed disposable valve, which is replaced every week, or 5 working days. It is intended to be used in-line on dental unit water lines as a means of preventing the retraction of orally contaminated fluids into the coolant and irrigant water hoses. It is to be used for all patients.
BACSTOP™ is to be installed within the last several inches of tubing, before the dental handpiece, air/water syringe or ultra sonic scaler. It opens only under sufficient pressure (equivalent to 1.5 psi) and snaps closed and seals against backflow when the pressure drops below this point. 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/K982009 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982009: One Week Backstop Dental Anti-Retraction Check Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982009
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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