510(k) · Cleared

Cleared

All-Bond 2

K910860510(k) TraditionalCleared Apr 29, 199168-day reviewClass II21 CFR 872.3200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bisco, Inc. · KLE Agent, Tooth Bonding, Resin

Cleared on Apr 29, 1991 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 76 later devices descend from it.

Decided: Apr 29, 1991
Review: 68 days
Class: Class II
Product code: KLE
Recalls: None
Predicates: 0

76 later devices descend from it, 7 citing it directly.

This deviceK910860 All-Bond 2Bisco, Inc. · 1991
Descendant · cites it directly · 67 of its ownK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
Descendant · cites it directly · 64 of its ownK990040 Clearfil SE BondKuraray Co. · 1999
Descendant · 2 generations on · 60 of its ownK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
Descendant · 3 generations on · 34 of its ownK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
Descendant · 4 generations on · 22 of its ownK094007 Unicem3M Espe AG Dental Products · 2010

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

1998high 7 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 76 · See all

K974486Clearfil Liner Bond 2VKuraray America, Inc. · 1998 · cites it directly67descendants
K990040Clearfil SE BondKuraray Co. · 1999 · cites it directly64descendants
K012442Modification to Clearfil SE BondKuraray Medical, Inc. · 2001 · 2 generations on60descendants
K032455Panavia F 2.0Kuraray Medical, Inc. · 2003 · 3 generations on34descendants
K094007Unicem3M Espe AG Dental Products · 2010 · 4 generations on22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K910860	All-Bond 2	Bisco, Inc.	1991	—
+1	K974486	Clearfil Liner Bond 2V	Kuraray America, Inc.	1998	—
+1	K990040	Clearfil SE Bond	Kuraray Co.	1999	—
+2	K012442	Modification to Clearfil SE Bond	Kuraray Medical, Inc.	2001	—
+3	K032455	Panavia F 2.0	Kuraray Medical, Inc.	2003	—
+4	K094007	Unicem	3M Espe AG Dental Products	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2001	2	0
2002	2	0
2003	3	0
2004	2	0
2005	2	0
2006	5	0
2007	4	0
2008	2	0
2009	3	0
2010	5	0
2011	4	0
2012	3	0
2013	6	0
2014	1	0
2015	4	0
2016	3	0
2017	2	0
2018	3	0
2019	7	0
2020	1	0
2021	2	0
2023	1	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K910860, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (76)

See all 76

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K974486	Clearfil Liner Bond 2V	Kuraray America, Inc.	1998	67
K990040	Clearfil SE Bond	Kuraray Co.	1999	64
K052501	Multiple Resin Tooth Bonding Agent	Cosmedent, Inc.	2005	3
K140537	TENURE4G	Den-Mat Holdings, LLC	2014	0
K102844	All-Bound 3	Bisco, Inc.	2010	0
K050647	All-in-One	Bisco, Inc.	2005	0
K992838	Adhere Conditioner, Adhere Primer, Adhere LC Adhesive, Adhere DC Adhere DC Activator…	Biomat Sciences, Inc.	1999	0

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, K974486 (Kuraray America, Inc., 1998) has gone furthest, with 67 descendants of its own.

How does its category compare?

All KLE devices

KLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLE

3in 2025

2007high 14 (2007) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLE

149in 2025

2007high 195 (2020) · low 61 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KLE

1in 2024

2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KLE

3in 2025

2007high 260 (2014) · low 3 (2025)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	—

https://510kreport.com/device/K910860 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910860: All-Bond 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910860

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026