510(k) · Cleared
ClearedIdodentine Disc, Idodentine Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Union Dental S.A. · EBG Crown And Bridge, Temporary, Resin
Cleared on Aug 14, 2015 as substantially equivalent to K071548 (Merz Dental GmbH, 2007) after a 176-day review. Its family tree reaches back 3 generations to 1994. 23 later devices descend from it.
- Decided
- Aug 14, 2015
- Review
- 176 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924830 (1994). 4 ancestors in all. 23 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK924830 Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 1994
- 2 generations backK060293 Temporary Crown and Bridge MaterialDentsply International, Inc. · 2006
- 1 generation backK071548 Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredMerz Dental GmbH · 2007
- This deviceK150432 Idodentine Disc, Idodentine BlockUnion Dental S.A. · 2015
- Descendant · cites it directly · 10 of its ownK190107 VeriSplintWhip Mix Corporation · 2019
- Descendant · 2 generations on · 6 of its ownK203000 KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries) · 2021 · Recalled
- Descendant · cites it directly · 3 of its ownK180578 Harvest Dental Polymer BlocksHarvest Dental Products, LLC · 2018
- Descendant · 3 generations on · 2 of its ownK211415 GR Splint Resin SystemPro3Dure Medical GmbH · 2021
- Descendant · 2 generations on · 2 of its ownK201173 E-GuardEnvisiontec GmbH · 2020 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K190107VeriSplintWhip Mix Corporation · 2019 · cites it directly10descendants
- K203000KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries) · 2021 · 2 generations on6descendants
- K180578Harvest Dental Polymer BlocksHarvest Dental Products, LLC · 2018 · cites it directly3descendants
- K211415GR Splint Resin SystemPro3Dure Medical GmbH · 2021 · 3 generations on2descendants
- K201173E-GuardEnvisiontec GmbH · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924830 | Luxatemp Automix | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1994 | — |
| −2 | K060293 | Temporary Crown and Bridge Material | Dentsply International, Inc. | 2006 | — |
| −1 | K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored | Merz Dental GmbH | 2007 | — |
| 0 (this device) | K150432 | Idodentine Disc, Idodentine Block | Union Dental S.A. | 2015 | — |
| +1 | K190107 | VeriSplint | Whip Mix Corporation | 2019 | — |
| +2 | K203000 | KeyPrint KeySplint Hard | Mycone Dental Supply Co. Inc. (Dba Keystone Industries) | 2021 | 1 |
| +1 | K180578 | Harvest Dental Polymer Blocks | Harvest Dental Products, LLC | 2018 | — |
| +3 | K211415 | GR Splint Resin System | Pro3Dure Medical GmbH | 2021 | — |
| +2 | K201173 | E-Guard | Envisiontec GmbH | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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 EBG? 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 EBG device
- #1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 generations · 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 |
|---|---|---|---|
| * | K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredSummary page 4…nce Company Predicate Device Intended use 510K nr MERZ Dental M-PM-DISC Temporary crown and K071548 GmbH (Tooth colored) bridges Reference predicates Company Pred… | 2007 |
| † | K134015 | M-PM-Disc | 2014 |
| † | K140758 | M-PM-Disc (Pink) | 2014 |
| † | K080556 | Artbloc Temp, Dimension: 15.5 X19.39 MM V-Classic Shades and Bleach Shades | 2008 |
What descends from it? (23)
See all 236 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190107 | VeriSplint | 2019 | 10 |
| K180578 | Harvest Dental Polymer Blocks | 2018 | 3 |
| K201683 | PMMA Block | 2020 | 2 |
| K180562 | Temp Basic, Temp Premium, Temp Premium Flexible, Multistratum Flexible, Therapon… | 2018 | 1 |
| K153490 | DD medical polymers | 2016 | 1 |
| K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | 2020 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K190107 (Whip Mix Corporation, 2019) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K071548.
How does its category compare?
All EBG devicesEBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · EBG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBG
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBG
1in 2025
MAUDE reports naming product code EBG, 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 | 3 | 64 | 0 | 4 |
| 2008 | 9 | 83 | 0 | 4 |
| 2009 | 2 | — | 1 | 1 |
| 2010 | 5 | 103 | 0 | 1 |
| 2011 | 10 | 96 | 0 | 1 |
| 2012 | 5 | 90 | 0 | 5 |
| 2013 | 2 | — | 0 | 11 |
| 2014 | 3 | 114 | 0 | 23 |
| 2015 | 6 | 209 | 0 | 26 |
| 2016 | 4 | 163 | 0 | 8 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 4 | 202 | 0 | 0 |
| 2019 | 6 | 98 | 0 | 6 |
| 2020 | 14 | 194 | 1 | 2 |
| 2021 | 3 | 265 | 0 | 4 |
| 2022 | 3 | 73 | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 5 | 144 | 0 | 0 |
| 2025 | 4 | 106 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Acrylic polymer blank particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM.
Indications:
- Temporary anterior and posterior crowns
- Temporary anterior and posterior bridges with up to two adjacent pontics
- Implant supported temporary restorations
Maximum recommended usage period: 12 months
- Removable structures for dentures (dental bases)
- Removable structures for therapeutic restorations (bite splints or occlusal splints)
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/K150432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150432: Idodentine Disc, Idodentine Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150432
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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