510(k) · Cleared
ClearedMajor.Repair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Major Prodotti Dentari S.P.A. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Nov 25, 2008 after a 118-day review. The FDA summary names no predicate by number. 24 later devices descend from it.
- Decided
- Nov 25, 2008
- Review
- 118 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 1 citing it directly.
- This deviceK082153 Major.RepairMajor Prodotti Dentari S.P.A. · 2008
- Descendant · cites it directly · 23 of its ownK102640 Vertex Self Curing, Vertex Castavaria, Vertex CastapressVertex-Dental B.V. · 2011
- Descendant · 2 generations on · 18 of its ownK130076 Promolux, Promolux HI, Weropress, Premeco PCSMerz Dental GmbH · 2013
- Descendant · 3 generations on · 17 of its ownK140758 M-PM-Disc (Pink)Merz Dental GmbH · 2014
- Descendant · 4 generations on · 14 of its ownK151142 Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling…Wieland Dental + Technik GmbH & Co. KG · 2015
- Descendant · 5 generations on · 7 of its ownK210977 E-Dent 1000Envisiontec GmbH · 2021
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K102640Vertex Self Curing, Vertex Castavaria, Vertex CastapressVertex-Dental B.V. · 2011 · cites it directly23descendants
- K130076Promolux, Promolux HI, Weropress, Premeco PCSMerz Dental GmbH · 2013 · 2 generations on18descendants
- K140758M-PM-Disc (Pink)Merz Dental GmbH · 2014 · 3 generations on17descendants
- K151142Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling LiquidWieland Dental + Technik GmbH & Co. KG · 2015 · 4 generations on14descendants
- K210977E-Dent 1000Envisiontec GmbH · 2021 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082153 | Major.Repair | Major Prodotti Dentari S.P.A. | 2008 | — |
| +1 | K102640 | Vertex Self Curing, Vertex Castavaria, Vertex Castapress | Vertex-Dental B.V. | 2011 | — |
| +2 | K130076 | Promolux, Promolux HI, Weropress, Premeco PCS | Merz Dental GmbH | 2013 | — |
| +3 | K140758 | M-PM-Disc (Pink) | Merz Dental GmbH | 2014 | — |
| +4 | K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid | Wieland Dental + Technik GmbH & Co. KG | 2015 | — |
| +5 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 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?
The FDA summary names no predicate by number.
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102640 | Vertex Self Curing, Vertex Castavaria, Vertex Castapress | 2011 | 23 |
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, K102640 (Vertex-Dental B.V., 2011) has gone furthest, with 23 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. 2008, 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?
Major.Repair is a cold-curing polymer for dental prosthesis. Poly-methylmethacrylate based. For reparing and rebasing dentures. Powder and liquid.
It is used to:
- repair and rebase prosthesis
- temporary prosthesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082153: Major.Repair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082153
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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