510(k) · Cleared
ClearedHarvest Printable Resin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harvest Dental Products, LLC · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on May 12, 2023 as substantially equivalent to K162572 (Vertex-Dental B.V., 2017) and 1 other predicate after a 268-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- May 12, 2023
- Review
- 268 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K924830 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK924830 Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 1994
- 5 generations backK060293 Temporary Crown and Bridge MaterialDentsply International, Inc. · 2006
- 4 generations backK071548 Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredMerz Dental GmbH · 2007
- 3 generations backK150432 Idodentine Disc, Idodentine BlockUnion Dental S.A. · 2015
- 2 generations backK190107 VeriSplintWhip Mix Corporation · 2019
- 1 generation backK201173 E-GuardEnvisiontec GmbH · 2020 · Recalled
- This deviceK222489 Harvest Printable ResinHarvest Dental Products, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924830 | Luxatemp Automix | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1994 | — |
| −5 | K060293 | Temporary Crown and Bridge Material | Dentsply International, Inc. | 2006 | — |
| −4 | K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored | Merz Dental GmbH | 2007 | — |
| −3 | K150432 | Idodentine Disc, Idodentine Block | Union Dental S.A. | 2015 | — |
| −2 | K190107 | VeriSplint | Whip Mix Corporation | 2019 | — |
| −1 | K201173 | E-Guard | Envisiontec GmbH | 2020 | 1 |
| 0 (this device) | K222489 | Harvest Printable Resin | Harvest Dental Products, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 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? (2)
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…II, ELM Product Code: Unclassified (Mouthguard), MQC 3. Predicate Device: Primary Predicate: NextDent Denture/E-Denture, Vertex-Dental B.V., K162572, Product Code EBI Secondary Predicate: E-Guard, EnvisionTEC GmbH, K201173, Product Code M… | 2017 |
| * | K201173 | E-GuardSummary page 4…NextDent Denture/E-Denture, Vertex-Dental B.V., K162572, Product Code EBI Secondary Predicate: E-Guard, EnvisionTEC GmbH, K201173, Product Code MQC, EBI 4. Device Description Harvest Printable Resin is a light-cured resin developed for additive manufactu… | 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 29 years and passes through 7 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 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. 2023, 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?
Harvest Printable Resin is indicated for the fabrication of dental bases for full removable dentures, artificial teeth, dental bite splints and guards and try-in devices, i.e., denture base and teeth. The material is an alternative to traditional heat-curable and auto-polymerizing resins and is intended for professional dental work only. This material is intended to be used by dental lab technicians and approved by licensed practitioners before being provided to the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222489: Harvest Printable Resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222489
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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