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, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Dec 17, 2024 as substantially equivalent to K231578 (Dentsply Sirona, 2023) and 1 other predicate after a 54-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Dec 17, 2024
- Review
- 54 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K011560 (2001). 11 ancestors in all, the oldest K924422 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 6 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 5 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 4 generations backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- 3 generations backK190043 Halley resinDentsply Sirona · 2019
- 2 generations backK191427 Halley resin systemDentsply Sirona · 2019
- 1 generation backK231578 Lucitone Digital Print Denture SystemDentsply Sirona · 2023
- This deviceK243336 Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −6 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −5 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −4 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| −3 | K190043 | Halley resin | Dentsply Sirona | 2019 | — |
| −2 | K191427 | Halley resin system | Dentsply Sirona | 2019 | — |
| −1 | K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | 2023 | — |
| 0 (this device) | 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 |
| 2020 | 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 |
|---|---|---|---|
| * | K231578 | Lucitone Digital Print Denture SystemSummary page 5…redicate Device: Primary Predicate Device 510(k) Company Name Lucitone Digital Print™ Denture System K231578 Dentsply Sirona Inc Secondary Predicate Device 510(k) Company Name De… | 2023 |
| * | K192806 | DENTCA Crown and BridgeSummary page 5…ply Sirona Inc Secondary Predicate Device 510(k) Company Name Dentca Crown and Bridge K192806 Dentca Inc 1 of 3 Dentsply Sirona ===… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K231578.
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. 2024, 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™ 3D Denture Base is a light-cured resin indicated for the fabrication of denture bases including full and partial dentures* and implant overdentures. * Lucitone Digital IPN™ 3D Premium Tooth is a light-cured resin intended for printing denture teeth. Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is intended for use as: * Printing resin for fabricating removable dentures for try-in and evaluation prior to fabrication…
Read the full statement (230 words)
* Lucitone Digital Print™ 3D Denture Base is a light-cured resin indicated for
the fabrication of denture bases including full and partial dentures* and implant overdentures.
* Lucitone Digital IPN™ 3D Premium Tooth is a light-cured resin intended for printing denture teeth.
Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is intended for use as:
* Printing resin for fabricating removable dentures for try-in and evaluation prior to fabrication of the
final denture.*
* Printing resin for fabricating a temporary denture.
* Printing resin for fabricating denture teeth in full arches and segments that will subsequently be
fused into a denture base.
* Printing resin for fabricating provisional crowns, bridges.**
* Lucitone Digital Fuse™ 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 Fuse™ 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 Fuse™ Step 3 — Total 3D Sealer is a light-cured sealant that produces a smooth,
glossy surface finish on the denture.
*Partial and full dentures are replacement for patients with missing teeth.†
**For instructions on printing provisional crowns and bridges with Lucitone Digital Value reference
Section G in IFU
†Statement added for EU MDR alignment.
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/K243336 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243336: Lucitone Digital Print Denture™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243336
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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