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 Sep 12, 2024 as substantially equivalent to K213765 (Prismatik Dentalcraft, Inc., 2022) after a 107-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Sep 12, 2024
- Review
- 107 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K011560 (2001). 8 ancestors in all. 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 backK191497 NextDent Denture 3D+Vertex-Dental B.V. · 2019
- 2 generations backK210298 GR-14 Resin SystemPro3Dure Medical GmbH · 2021
- 1 generation backK213765 Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc. · 2022
- This deviceK241493 Glidewell™ 3DP Denture Base ResinPrismatik Dentalcraft, 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 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019 | — |
| −2 | K210298 | GR-14 Resin System | Pro3Dure Medical GmbH | 2021 | — |
| −1 | K213765 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K213765 | Glidewell 3DP Denture Base ResinSummary page 5…enture relining, repairing, or rebasing resin Regulation Number: 872.3760 Product Code: EBI Legally Marketed Predicate Device (21 CFR 807.92(a)(3)) Predicate 510(k) #: K213765 Predicate Trade Name: Glidewell™ 3DP Denture Base Resin Product Code: EBI Device Description Summary (21 CFR 807.92(a)(4)) Glid… | 2022 |
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 2.2 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K213765.
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?
Glidewell Tm 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewel TM 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/K241493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241493: 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/K241493
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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