510(k) · Cleared
ClearedPromolux, Promolux HI, Weropress, Premeco PCS
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 Aug 22, 2013 as substantially equivalent to K102654 (Vertex-Dental B.V., 2010) and 1 other predicate after a 220-day review. Its family tree reaches back 3 generations to 1990. 18 later devices descend from it.
- Decided
- Aug 22, 2013
- Review
- 220 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K901789 (1990). 6 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK901789 Paladon (R) 65Kulzer, Inc. · 1990
- 2 generations backK081884 Major.Base 20Major Prodotti Dentari S.P.A. · 2008
- 1 generation backK102654 Vertex Rapid SimplifiedVertex-Dental B.V. · 2010
- This deviceK130076 Promolux, Promolux HI, Weropress, Premeco PCSMerz Dental GmbH · 2013
- Descendant · cites it directly · 17 of its ownK140758 M-PM-Disc (Pink)Merz Dental GmbH · 2014
- Descendant · 2 generations on · 14 of its ownK151142 Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling…Wieland Dental + Technik GmbH & Co. KG · 2015
- Descendant · 3 generations on · 7 of its ownK210977 E-Dent 1000Envisiontec GmbH · 2021
- Descendant · 4 generations on · 4 of its ownK222623 Digital CrownSprintray, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK230445 OnX ToughSprintray, Inc. · 2023
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K140758M-PM-Disc (Pink)Merz Dental GmbH · 2014 · cites it directly17descendants
- K151142Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling LiquidWieland Dental + Technik GmbH & Co. KG · 2015 · 2 generations on14descendants
- K210977E-Dent 1000Envisiontec GmbH · 2021 · 3 generations on7descendants
- K222623Digital CrownSprintray, Inc. · 2022 · 4 generations on4descendants
- K230445OnX ToughSprintray, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901789 | Paladon (R) 65 | Kulzer, Inc. | 1990 | — |
| −2 | K081884 | Major.Base 20 | Major Prodotti Dentari S.P.A. | 2008 | — |
| −1 | K102654 | Vertex Rapid Simplified | Vertex-Dental B.V. | 2010 | — |
| 0 (this device) | K130076 | Promolux, Promolux HI, Weropress, Premeco PCS | Merz Dental GmbH | 2013 | — |
| +1 | K140758 | M-PM-Disc (Pink) | Merz Dental GmbH | 2014 | — |
| +2 | K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid | Wieland Dental + Technik GmbH & Co. KG | 2015 | — |
| +3 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
| +4 | K222623 | Digital Crown | Sprintray, Inc. | 2022 | — |
| +3 | K230445 | OnX Tough | Sprintray, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K102654 | Vertex Rapid SimplifiedSummary page 1…Resin, Denture, Relining, Repairing, Rebasing (2ICFR 872.3760 Product Code EBI) Predicate Device: Vertex hot-curing denture base material (K102654) Vertex cold-cuing denture base material (K102640) Device Description: Mcrz Dental Denture Base Resins w… | 2010 |
| * | K102640 | Vertex Self Curing, Vertex Castavaria, Vertex CastapressSummary page 1…ICFR 872.3760 Product Code EBI) Predicate Device: Vertex hot-curing denture base material (K102654) Vertex cold-cuing denture base material (K102640) Device Description: Mcrz Dental Denture Base Resins with Prosthetic Color System are composed of the following products: *… | 2011 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140758 | M-PM-Disc (Pink) | 2014 | 17 |
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 23 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K140758 (Merz Dental GmbH, 2014) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K102654.
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. 2013, 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?
The Menz Dental GmbH Denture Base Resins with Prosthetic Color System (Promolux, Promolux Hi, Weropress and PremEco PCS) are indicated for:
Relining a denture surface that contacts tissue
Repairing a fractured denture, or
Fanning a new denture base
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130076: Promolux, Promolux HI, Weropress, Premeco PCS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130076
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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