510(k) · Cleared
ClearedProbase Hot and Probase Cold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar North America, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Oct 17, 1991 after a 65-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 26 later devices descend from it.
- Decided
- Oct 17, 1991
- Review
- 65 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 4 citing it directly.
- This deviceK913655 Probase Hot and Probase ColdIvoclar North America, Inc. · 1991
- Descendant · cites it directly · 23 of its ownK102640 Vertex Self Curing, Vertex Castavaria, Vertex CastapressVertex-Dental B.V. · 2011
- Descendant · cites it directly · 21 of its ownK081884 Major.Base 20Major Prodotti Dentari S.P.A. · 2008
- Descendant · cites it directly · 20 of its ownK102654 Vertex Rapid SimplifiedVertex-Dental B.V. · 2010
- 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
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K102640Vertex Self Curing, Vertex Castavaria, Vertex CastapressVertex-Dental B.V. · 2011 · cites it directly23descendants
- K081884Major.Base 20Major Prodotti Dentari S.P.A. · 2008 · cites it directly21descendants
- K102654Vertex Rapid SimplifiedVertex-Dental B.V. · 2010 · cites it directly20descendants
- K130076Promolux, Promolux HI, Weropress, Premeco PCSMerz Dental GmbH · 2013 · 2 generations on18descendants
- K140758M-PM-Disc (Pink)Merz Dental GmbH · 2014 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913655 | Probase Hot and Probase Cold | Ivoclar North America, Inc. | 1991 | — |
| +1 | K102640 | Vertex Self Curing, Vertex Castavaria, Vertex Castapress | Vertex-Dental B.V. | 2011 | — |
| +1 | K081884 | Major.Base 20 | Major Prodotti Dentari S.P.A. | 2008 | — |
| +1 | K102654 | Vertex Rapid Simplified | Vertex-Dental B.V. | 2010 | — |
| +2 | K130076 | Promolux, Promolux HI, Weropress, Premeco PCS | Merz Dental GmbH | 2013 | — |
| +3 | K140758 | M-PM-Disc (Pink) | Merz Dental GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (26)
See all 264 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?
- 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.
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 | — |
https://510kreport.com/device/K913655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913655: Probase Hot and Probase Cold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913655
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026