510(k) · Cleared
ClearedFusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prevest Denpro Limited · KLE Agent, Tooth Bonding, Resin
Cleared on Aug 11, 2023 as substantially equivalent to K110403 (Silmet, Ltd., 2011) and 2 other predicates after a 60-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Aug 11, 2023
- Review
- 60 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K931812 (1993). 35 ancestors in all, the oldest K871636 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 6 generations between
- 3 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- 2 generations backK111980 Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011
- 1 generation backK131432 Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE…Kuraray Noritake Dental, Inc. · 2013
- This deviceK231696 Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew…Prevest Denpro Limited · 2023
Show all 10 generations
- Root · 10 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 9 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 8 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 7 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 6 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 5 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 4 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 3 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- 2 generations backK111980 Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011
- 1 generation backK131432 Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE…Kuraray Noritake Dental, Inc. · 2013
- This deviceK231696 Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew…Prevest Denpro Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −9 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −8 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −7 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −6 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −5 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −4 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −3 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| −2 | K111980 | Clearfil Tri-S Bond Plus | Kuraray America, Inc. | 2011 | — |
| −1 | K131432 | Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2… | Kuraray Noritake Dental, Inc. | 2013 | — |
| 0 (this device) | K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K110403 | Prolink Adhesives (Prolink, Prolink SE)Summary page 6…nce devices use the same ISO standard for their testing. Their shelf lives are 3 years or are not given. Primary Predicate Device: Prolink and Prolink SE K110403 from SIlmet Additional Predicate Devices: Clearfil Photo Bond K943165 and Clearfil SE Bond 2 K131432 from Kuraray Reference Dev… | 2011 |
| * | K943165 | Clearfil Photo BondSummary page 6…ves are 3 years or are not given. Primary Predicate Device: Prolink and Prolink SE K110403 from SIlmet Additional Predicate Devices: Clearfil Photo Bond K943165 and Clearfil SE Bond 2 K131432 from Kuraray Reference Devices Used for Ingredients: Fusion Bond 5 - Adhese Universal (K133318) X… | 1994 |
| * | K131432 | Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Summary page 6…n. Primary Predicate Device: Prolink and Prolink SE K110403 from SIlmet Additional Predicate Devices: Clearfil Photo Bond K943165 and Clearfil SE Bond 2 K131432 from Kuraray Reference Devices Used for Ingredients: Fusion Bond 5 - Adhese Universal (K133318) XP Bond Dual Cure Universal Tota… | 2013 |
| † | K133318 | Adhese Universal | 2014 |
| † | K070538 | XP Bond Dual Cure Universal Total Etch Adhesive | 2007 |
| † | K212457 | Cal LC | |
| † | K060684 | Adper Prompt, Adper Prompt L-Pop | 2006 |
| † | K210804 | Adhese Universal DC, Cention Primer | 2022 |
| † | K992985 | Gluma Comfort Bond | 1999 |
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?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 35 ancestors has a recall.
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?
Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair. Fusion Bond 7 is indicated for bonding of composites to tooth structure, core build up, and adhesive cementation of crown & bridges, including inlays and onlays. Fusion Bond DC is indicated for direct light cure composite or compomer restorations, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.…
Read the full statement (166 words)
Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair.
Fusion Bond 7 is indicated for bonding of composites to tooth structure, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.
Fusion Bond DC is indicated for direct light cure composite or compomer restorations, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.
Renew MDP is indicated for bonding of dual cure, light cure or self cure composite or compomer restorations to tooth structure, treatment of hypersensitive teeth, and intraoral repairs of fractured restorations.
Renew Universal is indicated for direct bonding of light-cured composites, and compomers to tooth structure, bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured, intraoral repair of composite, metal-based and zirconia /alumina-based restorations, intraoral repair of ceramic restorations in combination with a silane coupling agent, treatment of hypersensitive teeth, and cavity sealing as a pretreatment for indirect restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231696: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231696
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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