510(k) · Cleared
ClearedIvobase Hybrid, Ivobase High Impact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Feb 17, 2011 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.
- Decided
- Feb 17, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK103391 Ivobase Hybrid, Ivobase High ImpactIvoclar Vivadent, Inc. · 2011
- Descendant · cites it directly · 14 of its ownK151142 Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling…Wieland Dental + Technik GmbH & Co. KG · 2015
- Descendant · 2 generations on · 7 of its ownK210977 E-Dent 1000Envisiontec GmbH · 2021
- Descendant · 3 generations on · 4 of its ownK222623 Digital CrownSprintray, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK230445 OnX ToughSprintray, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK242277 Crown HTSprintray, Inc. · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K151142Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling LiquidWieland Dental + Technik GmbH & Co. KG · 2015 · cites it directly14descendants
- K210977E-Dent 1000Envisiontec GmbH · 2021 · 2 generations on7descendants
- K222623Digital CrownSprintray, Inc. · 2022 · 3 generations on4descendants
- K230445OnX ToughSprintray, Inc. · 2023 · 2 generations on2descendants
- K242277Crown HTSprintray, Inc. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K103391 | Ivobase Hybrid, Ivobase High Impact | Ivoclar Vivadent, Inc. | 2011 | — |
| +1 | K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid | Wieland Dental + Technik GmbH & Co. KG | 2015 | — |
| +2 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
| +3 | K222623 | Digital Crown | Sprintray, Inc. | 2022 | — |
| +2 | K230445 | OnX Tough | Sprintray, Inc. | 2023 | — |
| +4 | K242277 | Crown HT | Sprintray, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid | 2015 | 14 |
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?
- Of its descendants, K151142 (Wieland Dental + Technik GmbH & Co. KG, 2015) has gone furthest, with 14 descendants of its own.
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. 2011, 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?
IvoBase, Hybrid and Ivoase High Impact are intended for the fabrication of PMMA based acrylic dental prosthesis including but not limited to partial and full dentures.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103391: Ivobase Hybrid, Ivobase High Impact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103391
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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