510(k) · Cleared
ClearedAll-Bond Universal w/BAC (not finalized)
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 Sep 9, 2016 as substantially equivalent to K112118 (Bisco, Inc., 2011) and 1 other predicate after a 148-day review. Its family tree reaches back 8 generations to 1990. 6 later devices descend from it.
- Decided
- Sep 9, 2016
- Review
- 148 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K900510 (1990). 42 ancestors in all, the oldest K833757 (1984). 6 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 7 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 6 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 5 generations backK020256 Unicem3M Espe AG Dental Products · 2002
- 4 generations backK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- 3 generations backK071131 UNO3M Espe AG Dental Products · 2007
- 2 generations backK110302 Adhesive Exl-7593M Espe AG · 2011
- 1 generation backK112118 DreambondBisco, Inc. · 2011
- This deviceK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK230465 Hi-Bond UniversalMediclus Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK240743 Peak Universal BondUltradent Products, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK213401 DIAPLUS UniversalDiaDent Group International · 2022
- Descendant · 3 generations on · 0 of its ownK262252 MPa Max adhesiveDen-Mat Holdings, LLC · 2026
- Descendant · cites it directly · 0 of its ownK261840 BracePaste Prime PlusAmerican Orthodontics · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K230465Hi-Bond UniversalMediclus Co., Ltd. · 2023 · cites it directly2descendants
- K240743Peak Universal BondUltradent Products, Inc. · 2024 · 2 generations on1descendant
- K213401DIAPLUS UniversalDiaDent Group International · 2022 · cites it directly1descendant
- K262252MPa Max adhesiveDen-Mat Holdings, LLC · 2026 · 3 generations on0descendants
- K261840BracePaste Prime PlusAmerican Orthodontics · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −7 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −6 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −5 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| −4 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| −3 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| −2 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| −1 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
| 0 (this device) | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
| +1 | K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | 2023 | — |
| +2 | K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024 | — |
| +1 | K213401 | DIAPLUS Universal | DiaDent Group International | 2022 | — |
| +3 | K262252 | MPa Max adhesive | Den-Mat Holdings, LLC | 2026 | — |
| +1 | K261840 | BracePaste Prime Plus | American Orthodontics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112118 | DreambondSummary page 4…e: Resin Tooth Bonding Agent Class II per 21 CFR 872.3200 Predicate Devices: Primary Predicate: DREAMBOND by Bisco, Inc. K112118, Agent, Tooth Bonding Resin - KLE Reference Predicate: PEAK UNIVERSAL BOND (Light Cure Resin Adhesive and Chlorhexidine)… | 2011 |
| * | K100752 | Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine)Summary page 4…isco, Inc. K112118, Agent, Tooth Bonding Resin - KLE Reference Predicate: PEAK UNIVERSAL BOND (Light Cure Resin Adhesive and Chlorhexidine), by Ultradent, K100752, Agent, Tooth Bonding Resin - KLE Indications for Use: ALL-BOND UNIVERSAL w/BAC adhesive is used for: 1. all direct restorat… | 2010 |
What descends from it? (6)
3 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?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 42 ancestors has a recall of any class.
- Of its descendants, K230465 (Mediclus Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K112118.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
1. all direct restorations
2. all indirect restorations
3. intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
4. desensitizing/sealing of tooth structure
5. protective varnish for glass ionomer fillings
6. priming of enamel for orthodontic use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161051: All-Bond Universal w/BAC (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/K161051
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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