510(k) · Cleared
ClearedJuvora Dentqal Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Juvora · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jan 23, 2014 as substantially equivalent to K123220 (Vertex-Dental B.V., 2013) and 1 other predicate after a 146-day review. Its family tree reaches back 2 generations to 2005. 8 later devices descend from it.
- Decided
- Jan 23, 2014
- Review
- 146 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K043504 (2005). 5 ancestors in all, the oldest K992956 (1999). 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK043504 PalaimpactHeraeus Kulzer, Inc. · 2005
- 1 generation backK111832 Paladon Ultra Powder (Pink), Paladon Ultra LiquidHeraeus Kulzer, LLC · 2011
- This deviceK132725 Juvora Dentqal DiscJuvora · 2014
- Descendant · cites it directly · 3 of its ownK160918 JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora · 2017
- Descendant · cites it directly · 3 of its ownK152113 BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016
- Descendant · 2 generations on · 1 of its ownK220329 G-CAMGraphenano Dental S.L. · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK253236 G-BlockGraphenano Dental S.L. · 2025
- Descendant · 2 generations on · 0 of its ownK233171 PF Keep; Cad Cam Keep BlockClemde SA DE CV · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K160918JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora · 2017 · cites it directly3descendants
- K152113BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016 · cites it directly3descendants
- K220329G-CAMGraphenano Dental S.L. · 2022 · 2 generations on1descendant
- K253236G-BlockGraphenano Dental S.L. · 2025 · 3 generations on0descendants
- K233171PF Keep; Cad Cam Keep BlockClemde SA DE CV · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K043504 | Palaimpact | Heraeus Kulzer, Inc. | 2005 | — |
| −1 | K111832 | Paladon Ultra Powder (Pink), Paladon Ultra Liquid | Heraeus Kulzer, LLC | 2011 | — |
| 0 (this device) | K132725 | Juvora Dentqal Disc | Juvora | 2014 | — |
| +1 | K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORA | Juvora | 2017 | — |
| +1 | K152113 | BioHPP - breCAM.BioHPP | Bredent GmbH & Co. KG | 2016 | — |
| +2 | K220329 | G-CAM | Graphenano Dental S.L. | 2022 | 1 |
| +3 | K253236 | G-Block | Graphenano Dental S.L. | 2025 | — |
| +2 | K233171 | PF Keep; Cad Cam Keep Block | Clemde SA DE CV | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K123220 | Vertex Thermosens RigidSummary page 1…872.3760, Product Code EBI; Regulatory Class 11) Legally Marketed Devices to Which Substantial Equivalence Is Claimed * Vertex Thermosens Rigid (K123220) * PaladonUltra (K111832) Device Description JUVORA"m Dental Discs are cylindrical, puck-shaped discs made from the implant-… | 2013 |
| * | K111832 | Paladon Ultra Powder (Pink), Paladon Ultra LiquidSummary page 1…60, Product Code EBI; Regulatory Class 11) Legally Marketed Devices to Which Substantial Equivalence Is Claimed * Vertex Thermosens Rigid (K123220) * PaladonUltra (K111832) Device Description JUVORA"m Dental Discs are cylindrical, puck-shaped discs made from the implant- grade polymer, PEEK-OPTlMAO… | 2011 |
What descends from it? (8)
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. 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?
The Juvora Dental Disc is a thermoplastic dental disc for the manufacture of full and partial removable dentures and implant overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132725: Juvora Dentqal Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132725
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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