510(k) · Cleared
ClearedFiteBac Cavity Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Largent Health, LLC · LBH Varnish, Cavity
Cleared on Jan 23, 2020 as substantially equivalent to K915668 (Bisco, Inc., 1992) after a 349-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Jan 23, 2020
- Review
- 349 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915668 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK915668 Bisco Cavity CleanserBisco, Inc. · 1992
- This deviceK190271 FiteBac Cavity CleanserLargent Health, LLC · 2020
- Descendant · cites it directly · 0 of its ownK233768 Papacarie DuoElevate Oral Care · 2024
- Descendant · cites it directly · 0 of its ownK200614 FiteBac Antimicrobial Cavity CleanserLargent Health, LLC · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915668 | Bisco Cavity Cleanser | Bisco, Inc. | 1992 | — |
| 0 (this device) | K190271 | FiteBac Cavity Cleanser | Largent Health, LLC | 2020 | — |
| +1 | K233768 | Papacarie Duo | Elevate Oral Care | 2024 | — |
| +1 | K200614 | FiteBac Antimicrobial Cavity Cleanser | Largent Health, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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 LBH? 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 LBH device
- #1 K262243 Profisil Freescore 12.9 · 4 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 |
|---|---|---|---|
| * | K915668 | Bisco Cavity CleanserSummary page 4…[email protected] Trade Name FiteBac® Cavity Cleanser Common Name Varnish, Cavity Code –Classification LBH: Class II Predicate Device K915668 Bisco Cavity Cleanser Reference Device K070070 Ascent Dental Cleanser Reference Device K163482 Lang Orthodontic Acr… | 1992 |
| † | K070070 | Ascent Dental Cleanser | 2007 |
| † | K163482 | Orthodontic Acrylic 2 | 2017 |
What descends from it? (2)
2 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 LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LBH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LBH
223in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBH
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBH
7in 2025
MAUDE reports naming product code LBH, 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 | 8 | 69 | 0 | 4 |
| 2008 | 6 | 79 | 0 | 3 |
| 2009 | 4 | 69 | 0 | 5 |
| 2010 | 7 | 107 | 0 | 7 |
| 2011 | 3 | 72 | 0 | 8 |
| 2012 | 4 | 83 | 0 | 7 |
| 2013 | 6 | 160 | 0 | 27 |
| 2014 | 6 | 204 | 3 | 40 |
| 2015 | 2 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 2 | 13 |
| 2019 | 2 | — | 1 | 9 |
| 2020 | 5 | 256 | 0 | 10 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 7 |
| 2023 | 3 | 167 | 0 | 8 |
| 2024 | 3 | 237 | 0 | 6 |
| 2025 | 4 | 223 | 0 | 7 |
| 2026 | 5 | 64 | 0 | — |
What is it indicated for?
The FiteBac® Cavity Cleanser is a 2% K21 QAS aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190271: FiteBac Cavity Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190271
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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