510(k) · Cleared
ClearedBisco Cavity Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Apr 21, 1992 after a 125-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.
- Decided
- Apr 21, 1992
- Review
- 125 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 4 citing it directly.
- This deviceK915668 Bisco Cavity CleanserBisco, Inc. · 1992
- Descendant · cites it directly · 4 of its ownK033938 Clearfil Protect BondKuraray Medical, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK190271 FiteBac Cavity CleanserLargent Health, LLC · 2020
- Descendant · 2 generations on · 2 of its ownK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK962065 3M Vitrebond Light Cure Glass Ionomer/Base3M Company · 1996
- Descendant · 2 generations on · 0 of its ownK233768 Papacarie DuoElevate Oral Care · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K033938Clearfil Protect BondKuraray Medical, Inc. · 2004 · cites it directly4descendants
- K190271FiteBac Cavity CleanserLargent Health, LLC · 2020 · cites it directly2descendants
- K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc. · 2015 · 2 generations on2descendants
- K9620653M Vitrebond Light Cure Glass Ionomer/Base3M Company · 1996 · cites it directly1descendant
- K233768Papacarie DuoElevate Oral Care · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915668 | Bisco Cavity Cleanser | Bisco, Inc. | 1992 | — |
| +1 | K033938 | Clearfil Protect Bond | Kuraray Medical, Inc. | 2004 | — |
| +1 | K190271 | FiteBac Cavity Cleanser | Largent Health, LLC | 2020 | — |
| +2 | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory… | Kuraray Noritake Dental, Inc. | 2015 | — |
| +1 | K962065 | 3M Vitrebond Light Cure Glass Ionomer/Base | 3M Company | 1996 | — |
| +2 | K233768 | Papacarie Duo | Elevate Oral Care | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (11)
See all 114 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?
- Of its descendants, K033938 (Kuraray Medical, Inc., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
https://510kreport.com/device/K915668 · printed Nov 4, 2026
Cite this page
510(k) Report. “K915668: Bisco Cavity Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915668
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026