510(k) · Cleared
ClearedAll-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch- 37 with Bac; Dark- Etch, Dark Etch (Blue- E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Aug 26, 2010 as substantially equivalent to K923842 (Bisco, Inc., 1992) after a 90-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- Aug 26, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923842 (1992). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK923842 Bisco Universal Bond-3Bisco, Inc. · 1992
- This deviceK101485 All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch-…Bisco, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK221450 Phosphoric Acid Etching GelRizhao Huge Biomaterials Company, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK140846 Eds Combo-RinseEssential Dental Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK133078 K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK113401 Ortho-1(Not Finalized)Bisco, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K221450Phosphoric Acid Etching GelRizhao Huge Biomaterials Company, Ltd. · 2022 · cites it directly0descendants
- K140846Eds Combo-RinseEssential Dental Systems, Inc. · 2014 · cites it directly0descendants
- K133078K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc. · 2013 · cites it directly0descendants
- K113401Ortho-1(Not Finalized)Bisco, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923842 | Bisco Universal Bond-3 | Bisco, Inc. | 1992 | — |
| 0 (this device) | K101485 | All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch-… | Bisco, Inc. | 2010 | — |
| +1 | K221450 | Phosphoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2022 | — |
| +1 | K140846 | Eds Combo-Rinse | Essential Dental Systems, Inc. | 2014 | — |
| +1 | K133078 | K-Etchant Syringe; Needle Tip (E) | Kuraray Noritake Dental, Inc. | 2013 | — |
| +1 | K113401 | Ortho-1(Not Finalized) | Bisco, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 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 KLE? 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 KLE device
- #1 K262252 MPa Max adhesivescore 15.1 · 11 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K094560 | Ecliptomer Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…marketed devices. Information is provided in this 5 10(k) submission demonstrating Ecliptomner (K0945604) and to the Bisco Etchants are substantially equivalent to the predicate devices… | |
| * | K923842 | Bisco Universal Bond-3Summary page 1…tially equivalent to the predicate devices for use, and chemical Bisco Universal Bond 3 (K923842) in terms of intended use, indications… | 1992 |
What descends from it? (4)
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?
- Its one ancestor has no recall.
- Of its descendants, K221450 (Rizhao Huge Biomaterials Company, Ltd., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 2025
MAUDE reports naming product code KLE, 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 | 14 | 71 | 2 | 18 |
| 2008 | 3 | 66 | 0 | 9 |
| 2009 | 7 | 79 | 1 | 11 |
| 2010 | 8 | 93 | 1 | 13 |
| 2011 | 10 | 100 | 0 | 69 |
| 2012 | 5 | 66 | 0 | 176 |
| 2013 | 11 | 115 | 0 | 248 |
| 2014 | 6 | 120 | 0 | 260 |
| 2015 | 10 | 118 | 0 | 100 |
| 2016 | 3 | 148 | 1 | 47 |
| 2017 | 4 | 171 | 1 | 42 |
| 2018 | 8 | 124 | 0 | 31 |
| 2019 | 6 | 143 | 0 | 20 |
| 2020 | 6 | 195 | 0 | 6 |
| 2021 | 4 | 163 | 0 | 6 |
| 2022 | 8 | 98 | 0 | 7 |
| 2023 | 6 | 75 | 0 | 7 |
| 2024 | 7 | 61 | 1 | 12 |
| 2025 | 3 | 149 | 0 | 3 |
| 2026 | 7 | 84 | 0 | — |
What is it indicated for?
Bisco Etchants consist of semi-gel phosphoric acids.
The principle uses of the Bisco Etchants are:
1. Etching and cleaning of dentin and enamel
2. Cleaning of restorative surfaces prior to bonding
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101485: All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch- 37 with Bac; Dark- Etch, Dark Etch (Blue- E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101485
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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