510(k) · Cleared
ClearedPalaseal (R)
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 16, 1989 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 16, 1989
- Review
- 67 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK892452 Palaseal (R)Kulzer, Inc. · 1989
- Descendant · cites it directly · 0 of its ownK150511 Coating MaterialSun Medical Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK093019 Enamelite Acryseal Spray SealantEnamelite, LLC · 2009
- Descendant · cites it directly · 0 of its ownK991161 Hydro-Cast Acrylic Varnish, Model 78125Kay See Dental Mfg. Co. · 1999
- Descendant · cites it directly · 0 of its ownK984341 Sternvantage Varnish LC, Model 221001Sterngold/Implamed · 1999
Most influential descendants
Showing 4 of 4 · See all- K150511Coating MaterialSun Medical Co., Ltd. · 2015 · cites it directly0descendants
- K093019Enamelite Acryseal Spray SealantEnamelite, LLC · 2009 · cites it directly0descendants
- K991161Hydro-Cast Acrylic Varnish, Model 78125Kay See Dental Mfg. Co. · 1999 · cites it directly0descendants
- K984341Sternvantage Varnish LC, Model 221001Sterngold/Implamed · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K892452 | Palaseal (R) | Kulzer, Inc. | 1989 | — |
| +1 | K150511 | Coating Material | Sun Medical Co., Ltd. | 2015 | — |
| +1 | K093019 | Enamelite Acryseal Spray Sealant | Enamelite, LLC | 2009 | — |
| +1 | K991161 | Hydro-Cast Acrylic Varnish, Model 78125 | Kay See Dental Mfg. Co. | 1999 | — |
| +1 | K984341 | Sternvantage Varnish LC, Model 221001 | Sterngold/Implamed | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 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? (4)
4 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, K150511 (Sun Medical Co., Ltd., 2015) has gone furthest, with 0 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/K892452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K892452: Palaseal (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K892452
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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