510(k) · Cleared
ClearedAscent Bond Universal Adhesive System, Models 006-00029, 006-00030, 006-00044, 006-00045
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CAO Group, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Oct 21, 2009 as substantially equivalent to K070413 (CAO Group, Inc., 2007) and 1 other predicate after a 56-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Oct 21, 2009
- Review
- 56 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K931812 (1993). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 5 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 4 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 3 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 2 generations backK982394 Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl. · 1998
- 1 generation backK070413 Ascent Universal Adhesive, Model 006-00028CAO Group, Inc. · 2007
- This deviceK092616 Ascent Bond Universal Adhesive System, Models 006-00029, 006-00030…CAO Group, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −5 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −4 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −3 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −2 | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive System | Dentsply Intl. | 1998 | — |
| −1 | K070413 | Ascent Universal Adhesive, Model 006-00028 | CAO Group, Inc. | 2007 | — |
| 0 (this device) | K092616 | Ascent Bond Universal Adhesive System, Models 006-00029, 006-00030, 006-00044… | CAO Group, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1999 | 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? (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 |
|---|---|---|---|
| * | K070413 | Ascent Universal Adhesive, Model 006-00028Summary page 1…Code: KLE) Legally Marketed Predicate Devices for Substantial Equivalence: , Ascent Universal Adhesive, Manufactured by CAO Group, Inc. 510(k) Number: K070413 * Gluma Comfort Bond + Desensitizer, Manufactured by Heraeus Kulzer, Inc. 510(k) Number: K992292 Rationale for Sub… | 2007 |
| * | K992292 | Gluma Comfort Bond + DesensitizerSummary page 1…ve, Manufactured by CAO Group, Inc. 510(k) Number: K070413 * Gluma Comfort Bond + Desensitizer, Manufactured by Heraeus Kulzer, Inc. 510(k) Number: K992292 Rationale for Substantial Equivalence: The aforementioned device shares similarities for use in the oral environment for… | 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 16 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Ascent Bond Universal Adhesive System is indicated for direct bonding to and desensitizing of dentin and enamel, and direct bonding to composite, porcelain, and base metals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092616 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092616: Ascent Bond Universal Adhesive System, Models 006-00029, 006-00030, 006-00044, 006-00045.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092616
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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