510(k) · Cleared
ClearedHalley resin system
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 Aug 26, 2019 as substantially equivalent to K190043 (Dentsply Sirona, 2019) after an 89-day review. Its family tree reaches back 5 generations to 2001. 3 later devices descend from it.
- Decided
- Aug 26, 2019
- Review
- 89 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K011560 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 4 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 3 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 2 generations backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- 1 generation backK190043 Halley resinDentsply Sirona · 2019
- This deviceK191427 Halley resin systemDentsply Sirona · 2019
- Descendant · cites it directly · 2 of its ownK231578 Lucitone Digital Print Denture SystemDentsply Sirona · 2023
- Descendant · 2 generations on · 0 of its ownK262300 Denture Base Resin V2Formlabs Ohio, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243336 Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −4 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −3 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −2 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| −1 | K190043 | Halley resin | Dentsply Sirona | 2019 | — |
| 0 (this device) | K191427 | Halley resin system | Dentsply Sirona | 2019 | — |
| +1 | K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | 2023 | — |
| +2 | K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026 | — |
| +2 | K243336 | Lucitone Digital Print Denture™ System | Dentsply Sirona, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231578 | Lucitone Digital Print Denture System | 2023 | 2 |
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 1.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K231578 (Dentsply Sirona, 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K190043.
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…
Read the full statement (120 words)
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.
Halley Denture-Tooth Bonding Agent is indicated for use in enhancing the bond of denture base to denture base.
Halley Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.
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/K191427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191427: Halley resin system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191427
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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