510(k) · Cleared
Recalled · Class III · 2024Stratasys TrueDent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stratasys, Ltd. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jul 7, 2022 as substantially equivalent to K210977 (Envisiontec GmbH, 2021) after a 113-day review. Its family tree reaches back 8 generations to 2004. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Jul 7, 2022
- Review
- 113 days
- Class
- Class II
- Product code
- EBI
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 8 generations to K042819 (2004). 30 ancestors in all, the oldest K901789 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 7 generations backK091388 GCUC-505GC America, Inc. · 2009
- 6 generations backK123631 MFP-051GC America, Inc. · 2013
- 5 generations backK133824 CerasmartGC America, Inc. · 2014
- 4 generations backK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- 3 generations backK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- 2 generations backK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- 1 generation backK210977 E-Dent 1000Envisiontec GmbH · 2021
- This deviceK220771 Stratasys TrueDentStratasys, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK241673 Denture Base Resin (PN-Denture (Red, White))Shenzhen Piocreat 3D Technology Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241673Denture Base Resin (PN-Denture (Red, White))Shenzhen Piocreat 3D 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 |
|---|---|---|---|---|---|
| −8 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −7 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −6 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| −5 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| −4 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| −3 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| −2 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| −1 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
| 0 (this device) | K220771 | Stratasys TrueDent | Stratasys, Ltd. | 2022 | — |
| +1 | K241673 | Denture Base Resin (PN-Denture (Red, White)) | Shenzhen Piocreat 3D Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K210977 | E-Dent 1000Summary page 4…Respiratory, ENT and Dental Devices) Reviewing Division Division of Health Technology 1 B (Dental and ENT Devices) PREDICATE DEVICE INFORMATION Primary Predicate: K210977, E-Dent 1000 (Flexcera Base & Smile), EnvisionTEC GmbH Reference Devices: K203641, E-Denture Pro Resin, EnvisionTEC E-Denture Pr… | 2021 |
| † | K203641 | E-Denture Pro | 2021 |
| † | K201827 | GR-17 Resin System | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241673 | Denture Base Resin (PN-Denture (Red, White)) | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2024 | Class III | Z-2091-2025 | Software design | Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired… |
| Jan 19, 2024 | Class III | Z-2094-2025 | Software design | Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired… |
| Jan 19, 2024 | Class III | Z-2090-2025 | Software design | Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired… |
| Jan 19, 2024 | Class III | Z-2093-2025 | Software design | Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired… |
| Jan 19, 2024 | Class III | Z-2092-2025 | Software design | Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 30 ancestors has a recall of any class.
- Of its descendants, K241673 (Shenzhen Piocreat 3D Technology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K210977.
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?
Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220771: Stratasys TrueDent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220771
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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