510(k) · Cleared
ClearedDentca Denture Base II
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 Mar 3, 2017 after a 221-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 16 later devices descend from it.
- Decided
- Mar 3, 2017
- Review
- 221 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 6 citing it directly.
- This deviceK162044 Dentca Denture Base IIDentca, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK221678 SprintRay High Impact Denture BaseSprintray, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK210298 GR-14 Resin SystemPro3Dure Medical GmbH · 2021
- Descendant · 2 generations on · 2 of its ownK230445 OnX ToughSprintray, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK213765 Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK240688 RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K221678SprintRay High Impact Denture BaseSprintray, Inc. · 2022 · cites it directly5descendants
- K210298GR-14 Resin SystemPro3Dure Medical GmbH · 2021 · cites it directly3descendants
- K230445OnX ToughSprintray, Inc. · 2023 · 2 generations on2descendants
- K213765Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc. · 2022 · 2 generations on2descendants
- K240688RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K162044 | Dentca Denture Base II | Dentca, Inc. | 2017 | — |
| +1 | K221678 | SprintRay High Impact Denture Base | Sprintray, Inc. | 2022 | — |
| +1 | K210298 | GR-14 Resin System | Pro3Dure Medical GmbH | 2021 | — |
| +2 | K230445 | OnX Tough | Sprintray, Inc. | 2023 | — |
| +2 | K213765 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2022 | — |
| +3 | K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (16)
See all 166 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?
- Of its descendants, K221678 (Sprintray, Inc., 2022) has gone furthest, with 5 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. 2017, 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 II is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins.
Fabrication of dental prosthetics with Dentca Denture Base II requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, stereolithographic additive printer, and curing light equipment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K162044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162044: Dentca Denture Base II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162044
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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