510(k) · Cleared
ClearedHi-Bond Universal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediclus Co., Ltd. · KLE Agent, Tooth Bonding, Resin
Cleared on May 22, 2023 as substantially equivalent to K161051 (Bisco, Inc., 2016) after a 90-day review. Its family tree reaches back 9 generations to 1990. 2 later devices descend from it.
- Decided
- May 22, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K900510 (1990). 43 ancestors in all, the oldest K833757 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 5 generations between
- 3 generations backK110302 Adhesive Exl-7593M Espe AG · 2011
- 2 generations backK112118 DreambondBisco, Inc. · 2011
- 1 generation backK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
- This deviceK230465 Hi-Bond UniversalMediclus Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK240743 Peak Universal BondUltradent Products, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK262252 MPa Max adhesiveDen-Mat Holdings, LLC · 2026
Show all 9 generations
- Root · 9 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 8 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 7 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 6 generations backK020256 Unicem3M Espe AG Dental Products · 2002
- 5 generations backK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- 4 generations backK071131 UNO3M Espe AG Dental Products · 2007
- 3 generations backK110302 Adhesive Exl-7593M Espe AG · 2011
- 2 generations backK112118 DreambondBisco, Inc. · 2011
- 1 generation backK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
- This deviceK230465 Hi-Bond UniversalMediclus Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −8 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −7 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −6 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| −5 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| −4 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| −3 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| −2 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
| −1 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
| 0 (this device) | K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | 2023 | — |
| +1 | K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024 | — |
| +2 | K262252 | MPa Max adhesive | Den-Mat Holdings, LLC | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K161051 | All-Bond Universal w/BAC (not finalized)Summary page 4…ssification: Class II, 21 CFR 872.3200 Classification Product Code: KLE 4. PrimaryPredicate Device: All-Bond Universal w/ BAC (K161051) by Bisco, Inc. 1 5. Device Description: The H… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240743 | Peak Universal Bond | 2024 | 1 |
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 33 years and passes through 7 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 43 ancestors has a recall of any class.
- Of its descendants, K240743 (Ultradent Products, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K161051.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230465: Hi-Bond Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230465
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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