510(k) · Cleared
Recalled · 2007Gluma Comfort Bond + Desensitizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Oct 1, 1999 after an 86-day review. The FDA summary names its predicate without a number. 41 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 1, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- KLE
- Recalls
- 2
- Predicates
- 0
41 later devices descend from it, 2 citing it directly.
- This deviceK992292 Gluma Comfort Bond + DesensitizerHeraeus Kulzer, Inc. · 1999
- Descendant · cites it directly · 39 of its ownK040857 Modification to Adper Prompt3M Espe AG Dental Products · 2004
- Descendant · 2 generations on · 38 of its ownK060684 Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products · 2006
- Descendant · 3 generations on · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 4 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
- Descendant · 5 generations on · 8 of its ownK112118 DreambondBisco, Inc. · 2011
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K040857Modification to Adper Prompt3M Espe AG Dental Products · 2004 · cites it directly39descendants
- K060684Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products · 2006 · 2 generations on38descendants
- K071131UNO3M Espe AG Dental Products · 2007 · 3 generations on35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 4 generations on34descendants
- K112118DreambondBisco, Inc. · 2011 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992292 | Gluma Comfort Bond + Desensitizer | Heraeus Kulzer, Inc. | 1999 | — |
| +1 | K040857 | Modification to Adper Prompt | 3M Espe AG Dental Products | 2004 | — |
| +2 | K060684 | Adper Prompt, Adper Prompt L-Pop | 3M Espe AG Dental Products | 2006 | — |
| +3 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +4 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +5 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | — | Bond -1 Named without a submission number | |
| * | — | ALL Bond 2 Named without a submission number | |
| * | — | 3M Single Bond Dental Adhesive Named without a submission number | |
| * | — | One Step Dental Adhesive Named without a submission number |
What descends from it? (41)
See all 412 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2007 | Not classified | Z-0035-2008 | Process design | The material may solidify in the bottle, and thus be rendered unusable. |
| Jul 9, 2007 | Not classified | Z-0036-2008 | Process design | The material may solidify in the bottle, and thus be rendered unusable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040857 (3M Espe AG Dental Products, 2004) has gone furthest, with 39 descendants of its own.
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?
Gluma Comfort Bond + Desensitizer is a light curing single component enamel/dentin adhesive for bonding of all current brands of resin composite restorative materials and compomers. It also provides adhesion to metals such as amalgam. Gluma Comfort Bond + Desensitizer combines primer and adhesive in a single bottle.
Serves as a desensitizer/preventative in dentin hypersensitivity conditions by means of sealing exposed dentinal tubules which effectively blocks the fluid flow in the tubules that cause sensitivity.
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/K992292 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992292: Gluma Comfort Bond + Desensitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992292
Report an extraction error
Are you the manufacturer?
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