510(k) · Cleared

Cleared

All-Bond Universal SC (Not Finalized)

K131734510(k) TraditionalCleared Apr 11, 2014302-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 11, 2014 as substantially equivalent to K063780 (Bisco, Inc., 2007) after a 302-day review. Its family tree reaches back 1 generation to 2007.

Decided: Apr 11, 2014
Review: 302 days
Class: Class II
Product code: KLE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K063780 (2007). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK063780 Ace Bond SEBisco, Inc. · 2007
This deviceK131734 All-Bond Universal SC (Not Finalized)Bisco, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K063780	Ace Bond SE	Bisco, Inc.	2007	—
0 (this device)	K131734	All-Bond Universal SC (Not Finalized)	Bisco, Inc.	2014	—

FIG. 1 — Lineage of K131734, 2007–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K063780	Ace Bond SE Summary page 1 …Class 11per 21 CFR 872.3200 Predicate Devices: All-Bond Universal SC is substantially equivalent to: ACE Bond SE by Bisco, Inc. Schaumburg IL K063780 Indications for Use: All-Bond Universal SC adhesive is used for: * Direct Restorations (e.g. resin-based compo…	Bisco, Inc.	2007	—

Also cleared against K063780: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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.
1 other device also cites its predicate K063780.

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. 2014, this device’s year, is highlighted.

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	—

What is it indicated for?

All-Bond Universal SC adhesive is used for:

* Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, core build-ups)

* Indirect Restorations (e.g. metal, glass, ceramics, zirconialalumlna)

* Bonding Resin or Primer for Substrates

* Desensitization/Sealing of Tooth

* lntraoral Repair (e.g. chipped porcelain, additions to direct restorations)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131734 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131734: All-Bond Universal SC (Not Finalized).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131734

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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