510(k) · Cleared
ClearedG-Block
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 Sep 29, 2025 as substantially equivalent to K220329 (Graphenano Dental S.L., 2022) after a 0-day review. Its family tree reaches back 5 generations to 2005.
- Decided
- Sep 29, 2025
- Review
- 0 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K043504 (2005). 8 ancestors in all, the oldest K992956 (1999). No later device cites it as a predicate yet.
- Root · 5 generations backK043504 PalaimpactHeraeus Kulzer, Inc. · 2005
- 4 generations backK111832 Paladon Ultra Powder (Pink), Paladon Ultra LiquidHeraeus Kulzer, LLC · 2011
- 3 generations backK132725 Juvora Dentqal DiscJuvora · 2014
- 2 generations backK160918 JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora · 2017
- 1 generation backK220329 G-CAMGraphenano Dental S.L. · 2022 · Recalled
- This deviceK253236 G-BlockGraphenano Dental S.L. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K043504 | Palaimpact | Heraeus Kulzer, Inc. | 2005 | — |
| −4 | K111832 | Paladon Ultra Powder (Pink), Paladon Ultra Liquid | Heraeus Kulzer, LLC | 2011 | — |
| −3 | K132725 | Juvora Dentqal Disc | Juvora | 2014 | — |
| −2 | K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORA | Juvora | 2017 | — |
| −1 | K220329 | G-CAM | Graphenano Dental S.L. | 2022 | 1 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K220329 | G-CAMSummary page 5…in SUBSEQUENT PRODUCT CODES: EBG – Crown and Bridge Temporary Resin III.PREDICATE DEVICE (21 CFR 807.92(a)(3)) Primary Predicate: K220329 G-CAM Reference Predicate: K160425 CAD/CAMouflage Milling Block IV. DEVICE DESCRIPTION (21 CF… | 2022 |
| † | K160425 | CAD/CAMouflage Milling Bock | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.
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/K253236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253236: G-Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253236
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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