510(k) · Cleared
ClearedPaladon (R) 65
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kulzer, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jun 22, 1990 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 84 later devices descend from it.
- Decided
- Jun 22, 1990
- Review
- 64 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
84 later devices descend from it, 3 citing it directly.
- This deviceK901789 Paladon (R) 65Kulzer, Inc. · 1990
- Descendant · cites it directly · 60 of its ownK991220 Vitron HEspe Dental AG · 1999
- Descendant · 2 generations on · 59 of its ownK992645 SinfonyEspe Dental AG · 1999
- 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 · cites it directly · 21 of its ownK081884 Major.Base 20Major Prodotti Dentari S.P.A. · 2008
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K991220Vitron HEspe Dental AG · 1999 · cites it directly60descendants
- K992645SinfonyEspe Dental AG · 1999 · 2 generations on59descendants
- K071131UNO3M Espe AG Dental Products · 2007 · 3 generations on35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 4 generations on34descendants
- K081884Major.Base 20Major Prodotti Dentari S.P.A. · 2008 · cites it directly21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901789 | Paladon (R) 65 | Kulzer, Inc. | 1990 | — |
| +1 | K991220 | Vitron H | Espe Dental AG | 1999 | — |
| +2 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| +3 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +4 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +1 | K081884 | Major.Base 20 | Major Prodotti Dentari S.P.A. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 10 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBI? 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 EBI device
- #1 K250617 Apex Flexscore 18.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (84)
See all 843 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?
- Of its descendants, K991220 (Espe Dental AG, 1999) has gone furthest, with 60 descendants of its own.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, 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 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
https://510kreport.com/device/K901789 · printed Nov 4, 2026
Cite this page
510(k) Report. “K901789: Paladon (R) 65.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K901789
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026