510(k) · Cleared
ClearedPalaxpress Ultra Powder (Pink); Palaxpress Ultra Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer, LLC · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Apr 29, 2011 as substantially equivalent to K902115 (Kulzer, Inc., 1990) after a 113-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Apr 29, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902115 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK902115 Palapress (R) Vario ResinKulzer, Inc. · 1990
- This deviceK110037 Palaxpress Ultra Powder (Pink); Palaxpress Ultra LiquidHeraeus Kulzer, LLC · 2011
- Descendant · cites it directly · 1 of its ownK130680 Acrytone, Rezen NF, and Iso Fast Denture ResinsDentsoll, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK170375 Nobilplast Denture ResinCmp Industries, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902115 | Palapress (R) Vario Resin | Kulzer, Inc. | 1990 | — |
| 0 (this device) | K110037 | Palaxpress Ultra Powder (Pink); Palaxpress Ultra Liquid | Heraeus Kulzer, LLC | 2011 | — |
| +1 | K130680 | Acrytone, Rezen NF, and Iso Fast Denture Resins | Dentsoll, Inc. | 2013 | — |
| +2 | K170375 | Nobilplast Denture Resin | Cmp Industries, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 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 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? (1)
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 |
|---|---|---|---|
| * | K902115 | Palapress (R) Vario ResinSummary page 1…ass-Il1 (3) Substantial equivalence PalaXpress ultra, liquid and powders, is substantially equivalent with Palapress vario, liquid and powders, 510(k) No. K902115 Main component of both liquids is methyl methacrylate and dimethacrylates, of the powders polymethyl methacrylate (… | 1990 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130680 | Acrytone, Rezen NF, and Iso Fast Denture Resins | 2013 | 1 |
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?
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. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Universal high fracture resistant denture base material. Used with injection or pouring techniques for fixed or removable dentures.
Injection procedure:
- Full maxillary and mandibular prostheses
- Implant over denture
Pouring procedure:
- Implant over denture
- Partial dentures. Multiple or single saddles
- Marginal contour and reshaping
- Repairs and additions
- Relines
- Dental splints
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110037 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110037: Palaxpress Ultra Powder (Pink); Palaxpress Ultra Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110037
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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