510(k) · Cleared
ClearedHalley resin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Apr 24, 2019 as substantially equivalent to K162572 (Vertex-Dental B.V., 2017) after a 105-day review. Its family tree reaches back 4 generations to 2001. 7 later devices descend from it.
- Decided
- Apr 24, 2019
- Review
- 105 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011560 (2001). 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 3 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 2 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 1 generation backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- This deviceK190043 Halley resinDentsply Sirona · 2019
- Descendant · cites it directly · 3 of its ownK191427 Halley resin systemDentsply Sirona · 2019
- Descendant · 2 generations on · 2 of its ownK231578 Lucitone Digital Print Denture SystemDentsply Sirona · 2023
- Descendant · cites it directly · 2 of its ownK220042 Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK262300 Denture Base Resin V2Formlabs Ohio, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260569 DB 4000 High Impact Denture BaseCarbon, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K191427Halley resin systemDentsply Sirona · 2019 · cites it directly3descendants
- K231578Lucitone Digital Print Denture SystemDentsply Sirona · 2023 · 2 generations on2descendants
- K220042Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc. · 2022 · cites it directly2descendants
- K262300Denture Base Resin V2Formlabs Ohio, Inc. · 2026 · 3 generations on0descendants
- K260569DB 4000 High Impact Denture BaseCarbon, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −3 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −2 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −1 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| 0 (this device) | K190043 | Halley resin | Dentsply Sirona | 2019 | — |
| +1 | K191427 | Halley resin system | Dentsply Sirona | 2019 | — |
| +2 | K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | 2023 | — |
| +1 | K220042 | Dentca Base Premium, Dentca Base Hi-Impact | Dentca, Inc. | 2022 | — |
| +3 | K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026 | — |
| +2 | K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K162572 | NextDent Denture, E-DentureSummary page 4…Rebasing ¢ CFR Number: 21 C.F.R. 872.3760 e Device Class: Il ¢ Product Code: EBI 3. Predicate Device: Predicate Device Name 510(k) Company Name NextDent™ Denture / E- K162572 Vertex-Dental BV Denture Reference Device: Reference Device Name 510(k) Company Name Pour Acrylic K161330 Dentsply Prostheti… | 2017 |
| † | K161330 | Pour Acrylic | 2016 |
What descends from it? (7)
2 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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K191427 (Dentsply Sirona, 2019) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K162572.
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. 2019, 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?
Halley resin is a light-cured resin indicated for the fabrication of dentures bases in dental laboratories, including full and partial dentures as well as implant overdentures, and other dental appliances. Halley resin can be used as a try-in material for evaluation prior to fabrication of the final restoration. Fabrication of these prostheses require a computer-aided design and manufacturing (CAD/CAM) system using an additive printer.
Halley resin can be utilized as an aid in bonding denture base to denture teeth as well as repair using traditional techniques.
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/K190043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190043: Halley resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190043
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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