510(k) · Cleared
ClearedFreeprint denture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Detax GmbH & Co. KG · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Nov 16, 2020 as substantially equivalent to K162572 (Vertex-Dental B.V., 2017) after a 265-day review. Its family tree reaches back 4 generations to 2001. 3 later devices descend from it.
- Decided
- Nov 16, 2020
- Review
- 265 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011560 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 3 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 2 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 1 generation backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- This deviceK200461 Freeprint dentureDetax GmbH & Co. KG · 2020
- Descendant · cites it directly · 0 of its ownK253324 UltraPrint-Dental Denture UVGuangzhou Heygears IMC., Inc. · 2025
- Descendant · cites it directly · 0 of its ownK252430 Freeprint® denture flexDetax GmbH · 2025
- Descendant · cites it directly · 0 of its ownK242884 Additively Manufactured Denture ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K253324UltraPrint-Dental Denture UVGuangzhou Heygears IMC., Inc. · 2025 · cites it directly0descendants
- K252430Freeprint® denture flexDetax GmbH · 2025 · cites it directly0descendants
- K242884Additively Manufactured Denture ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −3 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −2 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −1 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| 0 (this device) | K200461 | Freeprint denture | Detax GmbH & Co. KG | 2020 | — |
| +1 | K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | 2025 | — |
| +1 | K252430 | Freeprint® denture flex | Detax GmbH | 2025 | — |
| +1 | K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K162572 | NextDent Denture, E-DentureSummary page 4…epairing, or rebasing resin Classification 21 CFR 872.3760 Product Code: EBI Review Panel: Dental III. PREDICATE DEVICE K162572, NextDent™ Denture/E-Denture, Vertex-Dental BV., IV. DEVICE DESCRIPTION Description FREEPRINT denture is a light… | 2017 |
What descends from it? (3)
3 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 19 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K253324 (Guangzhou Heygears IMC., Inc., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K162572.
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. 2020, 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?
FREEPRINT denture is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures.
FREEPRINT denture is intended for continuous use in the oral environment, exclusively for professional dental work.
FREEPRINT denture can be used in combination with a stereolithographic 3D printer using a 385nm light source. A 3D-printer is not part of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200461: Freeprint denture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200461
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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