510(k) · Cleared
ClearedLucitone Digital Print Denture 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 Oct 20, 2023 as substantially equivalent to K191427 (Dentsply Sirona, 2019) and 1 other predicate after a 142-day review. Its family tree reaches back 6 generations to 2001. 2 later devices descend from it.
- Decided
- Oct 20, 2023
- Review
- 142 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K011560 (2001). 9 ancestors in all, the oldest K924422 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 5 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 4 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 3 generations backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- 2 generations backK190043 Halley resinDentsply Sirona · 2019
- 1 generation backK191427 Halley resin systemDentsply Sirona · 2019
- This deviceK231578 Lucitone Digital Print Denture SystemDentsply Sirona · 2023
- Descendant · cites it directly · 0 of its ownK262300 Denture Base Resin V2Formlabs Ohio, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK243336 Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc. · 2024
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 |
|---|---|---|---|---|---|
| −6 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −5 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −4 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −3 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| −2 | K190043 | Halley resin | Dentsply Sirona | 2019 | — |
| −1 | K191427 | Halley resin system | Dentsply Sirona | 2019 | — |
| 0 (this device) | K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | 2023 | — |
| +1 | K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026 | — |
| +1 | K243336 | Lucitone Digital Print Denture™ System | Dentsply Sirona, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K191427 | Halley resin systemSummary page 5…e Type Predicate Device Name 510(k) Company Name Primary Predicate Device Halley Resin System K191427 Dentsply Sirona Predicate Device Eclipse Bonding Agent K051707 Dentsply Sirona… | 2019 |
| * | K051707 | Eclipse Bonding AgentSummary page 5…ate Device Halley Resin System K191427 Dentsply Sirona Predicate Device Eclipse Bonding Agent K051707 Dentsply Sirona Reference Device Halley Resin K190043 Dentsply Sirona… | 2005 |
| † | K190043 | Halley resin | 2019 |
| † | K061264 | Tempfx Esthetic Provisional System | 2006 |
What descends from it? (2)
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 22 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K262300 (Formlabs Ohio, Inc., 2026) 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. 2023, 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?
* Lucitone Digital Print TM 3D Denture Base is a light-cured resin indicated for the fabrication of denture bases including full and partial dentures and implant overdentures, and implant overdentures and other dental appliances. * Lucitone Digital ValueT 3D Economy Tooth & Trial Placement is used as a try-in material for evaluation prior to fabrication of the final restoration or a temporary denture. * Lucitone Digital IPNTr 3D Premium Tooth is a…
Read the full statement (184 words)
* Lucitone Digital Print TM 3D Denture Base is a light-cured resin indicated for the fabrication of denture bases including full and partial dentures and implant overdentures, and implant overdentures and other dental appliances.
* Lucitone Digital ValueT 3D Economy Tooth & Trial Placement is used as a try-in material for evaluation prior to fabrication of the final restoration or a temporary denture.
* Lucitone Digital IPNTr 3D Premium Tooth is a light-cured resin intended for printing denture teeth.
* Lucitone Digital ValueT 3D Economy Tooth & Trial Placement is intended for printing full arch and tooth segments.
* Lucitone Digital FuseT r Step 1 - 3D Tooth Conditioning Agent is indicated for use in enhancing the bond of denture teeth to denture base and denture base to denture base.
* Lucitone Digital FuseTM Step 2 - 3D Denture Bonding Resin is utilized as an aid in bonding denture teeth to denture base as well as repair using traditional techniques.
* Lucitone Digital FuseTM Step 3 - Total 3D Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231578: Lucitone Digital Print Denture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231578
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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