510(k) · Cleared
ClearedVertex Thermosens Rigid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertex-Dental B.V. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Mar 1, 2013 as substantially equivalent to K053060 (Thermoplastic Comfort Systems, Inc., 2006) and 1 other predicate after a 137-day review. Its family tree reaches back 1 generation to 1999. 10 later devices descend from it.
- Decided
- Mar 1, 2013
- Review
- 137 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992956 (1999). 2 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992956 Lucitone FRS Flexibel Dental ResinDentsply Intl. · 1999
- This deviceK123220 Vertex Thermosens RigidVertex-Dental B.V. · 2013
- Descendant · cites it directly · 8 of its ownK132725 Juvora Dentqal DiscJuvora · 2014
- Descendant · 2 generations on · 3 of its ownK160918 JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora · 2017
- Descendant · 2 generations on · 3 of its ownK152113 BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016
- Descendant · 3 generations on · 1 of its ownK220329 G-CAMGraphenano Dental S.L. · 2022 · Recalled
- Descendant · 4 generations on · 0 of its ownK253236 G-BlockGraphenano Dental S.L. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K132725Juvora Dentqal DiscJuvora · 2014 · cites it directly8descendants
- K160918JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora · 2017 · 2 generations on3descendants
- K152113BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016 · 2 generations on3descendants
- K220329G-CAMGraphenano Dental S.L. · 2022 · 3 generations on1descendant
- K253236G-BlockGraphenano Dental S.L. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992956 | Lucitone FRS Flexibel Dental Resin | Dentsply Intl. | 1999 | — |
| 0 (this device) | K123220 | Vertex Thermosens Rigid | Vertex-Dental B.V. | 2013 | — |
| +1 | K132725 | Juvora Dentqal Disc | Juvora | 2014 | — |
| +2 | K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORA | Juvora | 2017 | — |
| +2 | K152113 | BioHPP - breCAM.BioHPP | Bredent GmbH & Co. KG | 2016 | — |
| +3 | K220329 | G-CAM | Graphenano Dental S.L. | 2022 | 1 |
| +4 | K253236 | G-Block | Graphenano Dental S.L. | 2025 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K053060 | TCS UnbreakableSummary page 1…ification Name, resin, denture, relining, repairing, rebasing Number & 872.3760 Product Code: EBI Predicate Devices: TCS@ Unbreakable - K053060 (Thermoplastic Comfort Systems, Inc.) Lucitone FRSW Flexible Dental Resin - K9… | 2006 |
| * | K992956 | Lucitone FRS Flexibel Dental ResinSummary page 1…e Devices: TCS@ Unbreakable - K053060 (Thermoplastic Comfort Systems, Inc.) Lucitone FRSW Flexible Dental Resin - K992956 (Denaply International) Device Description Device Description: Indicaton ofs Vertex m… | 1999 |
What descends from it? (10)
2 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?
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?
Vertex ThermoSens is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123220: Vertex Thermosens Rigid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123220
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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