510(k) · Cleared
ClearedHermes Bond 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG Dental Products · KLE Agent, Tooth Bonding, Resin
Cleared on Jan 10, 2005 as substantially equivalent to K020946 (3M Espe AG Dental Products, 2002) and 2 other predicates after a 67-day review. Its family tree reaches back 4 generations to 1990. 37 later devices descend from it.
- Decided
- Jan 10, 2005
- Review
- 67 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K900510 (1990). 13 ancestors in all, the oldest K873882 (1988). 37 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 3 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 2 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 1 generation backK020256 Unicem3M Espe AG Dental Products · 2002
- This deviceK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- Descendant · cites it directly · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 2 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
- Descendant · 3 generations on · 8 of its ownK112118 DreambondBisco, Inc. · 2011
- Descendant · 4 generations on · 6 of its ownK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
- Descendant · 3 generations on · 5 of its ownK153231 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K071131UNO3M Espe AG Dental Products · 2007 · cites it directly35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 2 generations on34descendants
- K112118DreambondBisco, Inc. · 2011 · 3 generations on8descendants
- K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016 · 4 generations on6descendants
- K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −3 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −2 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −1 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| 0 (this device) | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| +1 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +2 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +3 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
| +4 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
| +3 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | GC America, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (3)
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 |
|---|---|---|---|
| * | K020946 | Adper PromptSummary page 1…: ... Hermes Bond 2 Classification Name: ... SRUUUSUTU PP Resin tooth bonding agent Common Name: ..o Dental Adhesive Predicate Devices Adper Prompt L-Pop by SM ESPE ... K 020946 RelyX Unicemby SM ESPE................ K 020256 Protemp 3 Garant by 3M ... K 033022 510(k) Hermes Bond 2 4 510(k) Summary of S… | 2002 |
| * | K020256 | UnicemSummary page 1…USUTU PP Resin tooth bonding agent Common Name: ..o Dental Adhesive Predicate Devices Adper Prompt L-Pop by SM ESPE ... K 020946 RelyX Unicemby SM ESPE................ K 020256 Protemp 3 Garant by 3M ... K 033022 510(k) Hermes Bond 2 4 510(k) Summary of Safety and Effectiveness, page 4 of 139 === Page… | 2002 |
| * | K033022 | Protemp 3 GarantSummary page 1…mmon Name: ..o Dental Adhesive Predicate Devices Adper Prompt L-Pop by SM ESPE ... K 020946 RelyX Unicemby SM ESPE................ K 020256 Protemp 3 Garant by 3M ... K 033022 510(k) Hermes Bond 2 4 510(k) Summary of Safety and Effectiveness, page 4 of 139 3M ESPE… | 2003 |
What descends from it? (37)
See all 372 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 15 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K071131 (3M Espe AG Dental Products, 2007) has gone furthest, with 35 descendants of its own.
- 3 other devices also cite its predicate K020946.
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?
Bonding between dentin/enamel and silorane based composite filling materials
Bonding between dentin/enamel and methacrylate based composite filling materials
Bonding mediator for fissure sealing
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/K043043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043043: Hermes 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/K043043
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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