510(k) · Cleared
ClearedM-PM-Disc (Pink)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merz Dental GmbH · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Sep 15, 2014 as substantially equivalent to K130076 (Merz Dental GmbH, 2013) and 1 other predicate after a 173-day review. Its family tree reaches back 4 generations to 1990. 17 later devices descend from it.
- Decided
- Sep 15, 2014
- Review
- 173 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K901789 (1990). 11 ancestors in all. 17 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK901789 Paladon (R) 65Kulzer, Inc. · 1990
- 3 generations backK081884 Major.Base 20Major Prodotti Dentari S.P.A. · 2008
- 2 generations backK102654 Vertex Rapid SimplifiedVertex-Dental B.V. · 2010
- 1 generation backK130076 Promolux, Promolux HI, Weropress, Premeco PCSMerz Dental GmbH · 2013
- This deviceK140758 M-PM-Disc (Pink)Merz Dental GmbH · 2014
- 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 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · 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 |
|---|---|---|---|---|---|
| −4 | K901789 | Paladon (R) 65 | Kulzer, Inc. | 1990 | — |
| −3 | K081884 | Major.Base 20 | Major Prodotti Dentari S.P.A. | 2008 | — |
| −2 | K102654 | Vertex Rapid Simplified | Vertex-Dental B.V. | 2010 | — |
| −1 | K130076 | Promolux, Promolux HI, Weropress, Premeco PCS | Merz Dental GmbH | 2013 | — |
| 0 (this device) | K140758 | M-PM-Disc (Pink) | Merz Dental GmbH | 2014 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 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 |
|---|---|---|---|
| * | K130076 | Promolux, Promolux HI, Weropress, Premeco PCSSummary page 4…merz-dental.de August 5, 2014 M-PM-Disc (Pink) Denture Base Resin, Denture, Relining, Repairing, Rebasing Denture Resins ((e.g. Promolux) For Casting of Denture Bases K130076 Merz Dental GmbH M-PM-Disc (Tooth Colored) For Fabrication of Crowns and Bridges K071548 Merz Dental GmbH Page 14 of 22 ===… | 2013 |
| * | K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredSummary page 4…iring, Rebasing Denture Resins ((e.g. Promolux) For Casting of Denture Bases K130076 Merz Dental GmbH M-PM-Disc (Tooth Colored) For Fabrication of Crowns and Bridges K071548 Merz Dental GmbH Page 14 of 22 Intended Use Merz Dental GmbH M-PM-Disc (Pink) is a device for fabrication of d… | 2007 |
What descends from it? (17)
See all 172 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 24 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 11 ancestors has a recall.
- 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. 2014, 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?
Device for fabrication of dental bases for removable dentures.
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/K140758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140758: M-PM-Disc (Pink).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140758
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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