510(k) · Cleared
ClearedGlidewell 3DP Denture Base Resin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismatik Dentalcraft, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jun 22, 2022 as substantially equivalent to K210298 (Pro3Dure Medical GmbH, 2021) after a 203-day review. Its family tree reaches back 6 generations to 2001. 2 later devices descend from it.
- Decided
- Jun 22, 2022
- Review
- 203 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K011560 (2001). 7 ancestors in all. 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 backK191497 NextDent Denture 3D+Vertex-Dental B.V. · 2019
- 1 generation backK210298 GR-14 Resin SystemPro3Dure Medical GmbH · 2021
- This deviceK213765 Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK261802 Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK241493 Glidewell™ 3DP Denture Base ResinPrismatik Dentalcraft, 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 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019 | — |
| −1 | K210298 | GR-14 Resin System | Pro3Dure Medical GmbH | 2021 | — |
| 0 (this device) | K213765 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2022 | — |
| +1 | K261802 | Glidewell™ Denture Base Resin | Prismatik Dentalcraft, Inc. | 2026 | — |
| +1 | K241493 | Glidewell™ 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K210298 | GR-14 Resin SystemSummary page 4…3760) Regulatory Class: Class II Product Code: EBI III. PRIMARY PREDICATE DEVICE GR-14 Resin System (K210298) IV. DEVICE DESCRIPTION Glidewell™ 3DP Denture Base Resin is a light-cured resin for the fabrica… | 2021 |
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 21 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K261802 (Prismatik Dentalcraft, 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. 2022, 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?
Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213765: Glidewell 3DP Denture Base Resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213765
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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