510(k) · Cleared
Recalled · Class II · 2023G-CAM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graphenano Dental S.L. · EBF Material, Tooth Shade, Resin
Cleared on Aug 16, 2022 as substantially equivalent to K160918 (Juvora, 2017) after a 193-day review. Its family tree reaches back 4 generations to 2005. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 16, 2022
- Review
- 193 days
- Class
- Class II
- Product code
- EBF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K043504 (2005). 7 ancestors in all, the oldest K992956 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK043504 PalaimpactHeraeus Kulzer, Inc. · 2005
- 3 generations backK111832 Paladon Ultra Powder (Pink), Paladon Ultra LiquidHeraeus Kulzer, LLC · 2011
- 2 generations backK132725 Juvora Dentqal DiscJuvora · 2014
- 1 generation backK160918 JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora · 2017
- This deviceK220329 G-CAMGraphenano Dental S.L. · 2022
- Descendant · cites it directly · 0 of its ownK253236 G-BlockGraphenano Dental S.L. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253236G-BlockGraphenano Dental S.L. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K043504 | Palaimpact | Heraeus Kulzer, Inc. | 2005 | — |
| −3 | K111832 | Paladon Ultra Powder (Pink), Paladon Ultra Liquid | Heraeus Kulzer, LLC | 2011 | — |
| −2 | K132725 | Juvora Dentqal Disc | Juvora | 2014 | — |
| −1 | K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORA | Juvora | 2017 | — |
| 0 (this device) | K220329 | G-CAM | Graphenano Dental S.L. | 2022 | — |
| +1 | K253236 | G-Block | Graphenano Dental S.L. | 2025 | — |
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 |
|---|---|---|
| 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORASummary page 4…ENT PRODUCT CODES: EBG - Crown and Bridge Temporary Resin EBI - Denture Relining, Repairing, Rebasing Resin I.PREDICATE DEVICE (21 CFR 807.92(a)(3)) Primary Predicate: K160918 JUVORA Dental Disc Reference Predicate: K160425 CAD/CAMouflage Milling Block IV. DEVICE DESCRIPTION (21 CFR 807.92(3)(4)) G-CA… | 2017 |
| † | K160425 | CAD/CAMouflage Milling Bock | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253236 | G-Block | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2023 | Class II | Z-1192-2024 | Process control | Machining error on cams renders the device unusable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K253236 (Graphenano Dental S.L., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K160918.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
G-CAM discs are intended to be used for the manufacture of full and partial removable dentures, implant overdentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, onlays, vencers, copings and substructures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220329: G-CAM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220329
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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