510(k) · Cleared
ClearedIvobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wieland Dental + Technik GmbH & Co. KG · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Aug 13, 2015 as substantially equivalent to K140758 (Merz Dental GmbH, 2014) and 3 other predicates after a 106-day review. Its family tree reaches back 5 generations to 1990. 14 later devices descend from it.
- Decided
- Aug 13, 2015
- Review
- 106 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K901789 (1990). 14 ancestors in all. 14 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK901789 Paladon (R) 65Kulzer, Inc. · 1990
- 4 generations backK081884 Major.Base 20Major Prodotti Dentari S.P.A. · 2008
- 3 generations backK102654 Vertex Rapid SimplifiedVertex-Dental B.V. · 2010
- 2 generations backK130076 Promolux, Promolux HI, Weropress, Premeco PCSMerz Dental GmbH · 2013
- 1 generation backK140758 M-PM-Disc (Pink)Merz Dental GmbH · 2014
- This deviceK151142 Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling…Wieland Dental + Technik GmbH & Co. KG · 2015
- Descendant · cites it directly · 7 of its ownK210977 E-Dent 1000Envisiontec GmbH · 2021
- Descendant · 2 generations on · 4 of its ownK222623 Digital CrownSprintray, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK230445 OnX ToughSprintray, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK242277 Crown HTSprintray, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK240688 RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K210977E-Dent 1000Envisiontec GmbH · 2021 · cites it directly7descendants
- K222623Digital CrownSprintray, Inc. · 2022 · 2 generations on4descendants
- K230445OnX ToughSprintray, Inc. · 2023 · cites it directly2descendants
- K242277Crown HTSprintray, Inc. · 2024 · 3 generations on1descendant
- K240688RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901789 | Paladon (R) 65 | Kulzer, Inc. | 1990 | — |
| −4 | K081884 | Major.Base 20 | Major Prodotti Dentari S.P.A. | 2008 | — |
| −3 | K102654 | Vertex Rapid Simplified | Vertex-Dental B.V. | 2010 | — |
| −2 | K130076 | Promolux, Promolux HI, Weropress, Premeco PCS | Merz Dental GmbH | 2013 | — |
| −1 | K140758 | M-PM-Disc (Pink) | Merz Dental GmbH | 2014 | — |
| 0 (this device) | K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid | Wieland Dental + Technik GmbH & Co. KG | 2015 | — |
| +1 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
| +2 | K222623 | Digital Crown | Sprintray, Inc. | 2022 | — |
| +1 | K230445 | OnX Tough | Sprintray, Inc. | 2023 | — |
| +3 | K242277 | Crown HT | Sprintray, Inc. | 2024 | — |
| +2 | K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (4)
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 |
|---|---|---|---|
| * | K140758 | M-PM-Disc (Pink)Summary page 4…Classification Code EBI Predicate Devices: IvoBase CAD for Zenotec is substantially equivalent to: (Primary Predicate) - M-PM-Disc (Pink) (K140758) marketed by Merz Dental GmbH. - SR Ivocap Plus (K915377) manufactured by Ivoclar Vivadent, AG… | 2014 |
| * | K915377 | SR-Ivocap PlusSummary page 4…ec is substantially equivalent to: (Primary Predicate) - M-PM-Disc (Pink) (K140758) marketed by Merz Dental GmbH. - SR Ivocap Plus (K915377) manufactured by Ivoclar Vivadent, AG - Probase Hot and Cold (K913655)… | 1992 |
| * | K913655 | Probase Hot and Probase ColdSummary page 4…ed by Merz Dental GmbH. - SR Ivocap Plus (K915377) manufactured by Ivoclar Vivadent, AG - Probase Hot and Cold (K913655) - Ivobase Hybrid, Ivobase High Impact (K103391) both manufactured by I… | 1991 |
| * | K103391 | Ivobase Hybrid, Ivobase High ImpactSummary page 4…7) manufactured by Ivoclar Vivadent, AG - Probase Hot and Cold (K913655) - Ivobase Hybrid, Ivobase High Impact (K103391) both manufactured by Ivoclar Vivadent, AG. Device Description: IvoBase CAD for Zenotec is prese… | 2011 |
What descends from it? (14)
See all 144 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 25 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K210977 (Envisiontec GmbH, 2021) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K140758.
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. 2015, 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 CAD for Zenotec, IvoBase CAD Bond and Modelling Liquid is a system used:
For the fabrication of removable dentures.e.g.:
partial and complete denture prosthetics
hybrd denture prosthetics
combined denture prosthetics
mouthguards
implant-supported denture prosthetics
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/K151142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151142: Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151142
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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