510(k) · Cleared
ClearedJUVORA Dental Disc, Ceramill PEEK by JUVORA
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 Feb 13, 2017 as substantially equivalent to K132725 (Juvora, 2014) after a 315-day review. Its family tree reaches back 3 generations to 2005. 3 later devices descend from it.
- Decided
- Feb 13, 2017
- Review
- 315 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K043504 (2005). 6 ancestors in all, the oldest K992956 (1999). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK043504 PalaimpactHeraeus Kulzer, Inc. · 2005
- 2 generations backK111832 Paladon Ultra Powder (Pink), Paladon Ultra LiquidHeraeus Kulzer, LLC · 2011
- 1 generation backK132725 Juvora Dentqal DiscJuvora · 2014
- This deviceK160918 JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora · 2017
- Descendant · cites it directly · 1 of its ownK220329 G-CAMGraphenano Dental S.L. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK253236 G-BlockGraphenano Dental S.L. · 2025
- Descendant · cites it directly · 0 of its ownK233171 PF Keep; Cad Cam Keep BlockClemde SA DE CV · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K043504 | Palaimpact | Heraeus Kulzer, Inc. | 2005 | — |
| −2 | K111832 | Paladon Ultra Powder (Pink), Paladon Ultra Liquid | Heraeus Kulzer, LLC | 2011 | — |
| −1 | K132725 | Juvora Dentqal Disc | Juvora | 2014 | — |
| 0 (this device) | K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORA | Juvora | 2017 | — |
| +1 | K220329 | G-CAM | Graphenano Dental S.L. | 2022 | 1 |
| +2 | K253236 | G-Block | Graphenano Dental S.L. | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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? (1)
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.
What descends from it? (3)
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K220329 (Graphenano Dental S.L., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K132725.
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. 2017, 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. They are intended to be used for the manufacture of:
i) full and partial removable dentures and implant overdentures.
ii) copings, substructures (cemented or uncemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160918: JUVORA Dental Disc, Ceramill PEEK by JUVORA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160918
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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