510(k) · Cleared
ClearedDentca Denture Base
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentca, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jul 21, 2015 as substantially equivalent to K032892 (Dentsply Intl., 2003) after a 272-day review. Its family tree reaches back 2 generations to 2001. 30 later devices descend from it.
- Decided
- Jul 21, 2015
- Review
- 272 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011560 (2001). 30 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 1 generation backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- This deviceK143033 Dentca Denture BaseDentca, Inc. · 2015
- Descendant · cites it directly · 28 of its ownK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- Descendant · 2 generations on · 13 of its ownK191497 NextDent Denture 3D+Vertex-Dental B.V. · 2019
- Descendant · 2 generations on · 7 of its ownK190043 Halley resinDentsply Sirona · 2019
- Descendant · 3 generations on · 3 of its ownK210298 GR-14 Resin SystemPro3Dure Medical GmbH · 2021
- Descendant · 3 generations on · 3 of its ownK203641 E-Denture ProEnvisiontec GmbH · 2021
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K162572NextDent Denture, E-DentureVertex-Dental B.V. · 2017 · cites it directly28descendants
- K191497NextDent Denture 3D+Vertex-Dental B.V. · 2019 · 2 generations on13descendants
- K190043Halley resinDentsply Sirona · 2019 · 2 generations on7descendants
- K210298GR-14 Resin SystemPro3Dure Medical GmbH · 2021 · 3 generations on3descendants
- K203641E-Denture ProEnvisiontec GmbH · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −1 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| 0 (this device) | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| +1 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| +2 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019 | — |
| +2 | K190043 | Halley resin | Dentsply Sirona | 2019 | — |
| +3 | K210298 | GR-14 Resin System | Pro3Dure Medical GmbH | 2021 | — |
| +3 | K203641 | E-Denture Pro | Envisiontec GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K032892 | Modification to Trubyte Denture Base Resin SystemSummary page 4…Class: 2 Medical Specialty: Dental Primary Predicate Device The following primary predicate is a legally marketed, post-amendment device: 510(k) Number: K032892 Clearance Date: September 26, 2003 510(k) Trade Name: Trubyte Denture Base Resin System Actual trade names: Trubyte Tr… | 2003 |
| † | K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing System | 2011 |
What descends from it? (30)
See all 302 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 14 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162572 (Vertex-Dental B.V., 2017) has gone furthest, with 28 descendants of its own.
- 2 other devices also cite its predicate K032892.
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. 2015, 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?
Dentca Denture Base is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-cured and auto polymerizing resins.
Fabrication of dental prosthetics with Dentca Denture Base requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143033: Dentca Denture Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143033
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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