510(k) · Cleared
ClearedBisfil 2B
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 Nov 5, 1996 after a 29-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Nov 5, 1996
- Review
- 29 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK964000 Bisfil 2BBisco, Inc. · 1996
- Descendant · cites it directly · 9 of its ownK012307 Luxacore/Luxacore DualDmg USA, Inc. · 2001
- Descendant · 2 generations on · 1 of its ownK143104 Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XKettenbach GmbH & Co. KG · 2015
- Descendant · 2 generations on · 1 of its ownK092572 Core*IT DualSpident Co., Ltd. · 2009
- Descendant · 2 generations on · 1 of its ownK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK262982 Core·it DualSpident Co., Ltd. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K012307Luxacore/Luxacore DualDmg USA, Inc. · 2001 · cites it directly9descendants
- K143104Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XKettenbach GmbH & Co. KG · 2015 · 2 generations on1descendant
- K092572Core*IT DualSpident Co., Ltd. · 2009 · 2 generations on1descendant
- K041960Composite/Compomer Repair KitDmg USA, Inc. · 2004 · 2 generations on1descendant
- K262982Core·it DualSpident Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964000 | Bisfil 2B | Bisco, Inc. | 1996 | — |
| +1 | K012307 | Luxacore/Luxacore Dual | Dmg USA, Inc. | 2001 | — |
| +2 | K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | Kettenbach GmbH & Co. KG | 2015 | — |
| +2 | K092572 | Core*IT Dual | Spident Co., Ltd. | 2009 | — |
| +2 | K041960 | Composite/Compomer Repair Kit | Dmg USA, Inc. | 2004 | — |
| +3 | K262982 | Core·it Dual | Spident Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Bisfil II Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012307 | Luxacore/Luxacore Dual | 2001 | 9 |
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, K012307 (Dmg USA, Inc., 2001) has gone furthest, with 9 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.
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?
BISFIL 2B is indicated for use as a base increment posterior composite. It is intended to be used with ALL-BOND 2® or ONE-STEP™, or similar universal dental adhesive system. BISFIL 2B will bond to the enamel / dentin bonding system such as ONE-STEP. BISFIL 2B is intended to be covered by a high quality light-cure composite.
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/K964000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964000: Bisfil 2B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964000
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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