510(k) · Cleared
ClearedGluma One Bond
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 Feb 4, 1998 after a 75-day review. The FDA summary names no predicate by number. 65 later devices descend from it.
- Decided
- Feb 4, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
65 later devices descend from it, 1 citing it directly.
- This deviceK974390 Gluma One BondHeraeus Kulzer, Inc. · 1998
- Descendant · cites it directly · 64 of its ownK990040 Clearfil SE BondKuraray Co. · 1999
- Descendant · 2 generations on · 60 of its ownK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- Descendant · 3 generations on · 34 of its ownK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- Descendant · 4 generations on · 22 of its ownK094007 Unicem3M Espe AG Dental Products · 2010
- Descendant · 4 generations on · 19 of its ownK100756 MALTA3M Espe AG Dental Products · 2010
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K990040Clearfil SE BondKuraray Co. · 1999 · cites it directly64descendants
- K012442Modification to Clearfil SE BondKuraray Medical, Inc. · 2001 · 2 generations on60descendants
- K032455Panavia F 2.0Kuraray Medical, Inc. · 2003 · 3 generations on34descendants
- K094007Unicem3M Espe AG Dental Products · 2010 · 4 generations on22descendants
- K100756MALTA3M Espe AG Dental Products · 2010 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974390 | Gluma One Bond | Heraeus Kulzer, Inc. | 1998 | — |
| +1 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| +2 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| +3 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| +4 | K094007 | Unicem | 3M Espe AG Dental Products | 2010 | — |
| +4 | K100756 | MALTA | 3M Espe AG Dental Products | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (65)
See all 651 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990040 | Clearfil SE Bond | 1999 | 64 |
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?
- Of its descendants, K990040 (Kuraray Co., 1999) has gone furthest, with 64 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 ONE BOND is a light curing single component enamel/dentin adhesive for bonding of all current brands of resin composite restorative materials and compomers. It also enhances adhesion to metals such as amalgam. GLUMA ONE BOND combines primer and adhesive in single bottle.
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/K974390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974390: Gluma One Bond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974390
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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