510(k) · Cleared
ClearedUltraPrint-Dental Denture UV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Heygears IMC., Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Nov 20, 2025 as substantially equivalent to K200461 (Detax GmbH & Co. KG, 2020) after a 51-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Nov 20, 2025
- Review
- 51 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K011560 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 4 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 3 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 2 generations backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- 1 generation backK200461 Freeprint dentureDetax GmbH & Co. KG · 2020
- This deviceK253324 UltraPrint-Dental Denture UVGuangzhou Heygears IMC., Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −4 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −3 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −2 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| −1 | K200461 | Freeprint denture | Detax GmbH & Co. KG | 2020 | — |
| 0 (this device) | K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K200461 | Freeprint dentureSummary page 5…ice in this submission is substantially equivalent in indications, use and design principles to the following Predicate device 510(k) Predicate Device Name Company Name K200461 FREEPRINT denture DETAX GmbH & Co.KG. INDICATION FOR USE UltraPrint-Dental Denture UV is indicated for the fabrication of all t… | 2020 |
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 24 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K200461.
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. 2025, 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?
UltraPrint-Dental Denture UV is indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures.
UltraPrint-Dental Denture UV is intended for continuous use in the oral environment, exclusively for professional dental work.
UltraPrint-Dental Denture UV can be used in combination with a 3D printer using a 385nm light source. A 3D-printer is not part of the device.
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/K253324 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253324: UltraPrint-Dental Denture UV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253324
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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