510(k) · Cleared
ClearedGlidewell™ 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 Aug 27, 2026 as substantially equivalent to K213765 (Prismatik Dentalcraft, Inc., 2022) after an 87-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Aug 27, 2026
- Review
- 87 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 deviceK261802 Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc. · 2026
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) | K261802 | Glidewell™ Denture Base Resin | Prismatik Dentalcraft, Inc. | 2026 | — |
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 Reference 510(k) #: K241493 Reference Device Trade Name… | 2022 |
| † | K241493 | Glidewell™ 3DP Denture Base Resin | 2024 |
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 25 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. 2026, 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™ Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
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/K261802 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261802: Glidewell™ Denture Base Resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261802
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026