510(k) · Cleared
Recalled · Class II · 2026Grandio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voco GmbH · EBF Material, Tooth Shade, Resin
Cleared on Jul 27, 2005 after a 16-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 27, 2005
- Review
- 16 days
- Class
- Class II
- Product code
- EBF
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK051867 GrandioVoco GmbH · 2005
- Descendant · cites it directly · 1 of its ownK103190 Profil Composites (Profil, Profil Flow)Silmet, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK102351 Grandio SOVoco GmbH · 2010
- Descendant · 2 generations on · 0 of its ownK220077 IMICRYL Composite, Composite Flow MaterialsImicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2022
- Descendant · 2 generations on · 0 of its ownK190139 Zircos-ComBioden Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK072150 Dimer Acid Derived Nano-Hybrid Composite Restorative MaterialNovocol, Inc. · 2007
Most influential descendants
Showing 5 of 5 · See all- K103190Profil Composites (Profil, Profil Flow)Silmet, Ltd. · 2011 · cites it directly1descendant
- K102351Grandio SOVoco GmbH · 2010 · cites it directly1descendant
- K220077IMICRYL Composite, Composite Flow MaterialsImicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2022 · 2 generations on0descendants
- K190139Zircos-ComBioden Co., Ltd. · 2020 · 2 generations on0descendants
- K072150Dimer Acid Derived Nano-Hybrid Composite Restorative MaterialNovocol, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051867 | Grandio | Voco GmbH | 2005 | — |
| +1 | K103190 | Profil Composites (Profil, Profil Flow) | Silmet, Ltd. | 2011 | — |
| +1 | K102351 | Grandio SO | Voco GmbH | 2010 | — |
| +2 | K220077 | IMICRYL Composite, Composite Flow Materials | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2022 | — |
| +2 | K190139 | Zircos-Com | Bioden Co., Ltd. | 2020 | — |
| +1 | K072150 | Dimer Acid Derived Nano-Hybrid Composite Restorative Material | Novocol, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2026 | Class II | Z-3016-2026 | Process control | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K103190 (Silmet, Ltd., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Fillings of class I-V
Reconstruction of traumatically affected anteriors
Facetting of discolored anteriors
Correction of shape and shade for better aesthetic appearance
Locking, splinting of loose anteriors
Repair of veneers
Filling of deciduous teeth
Core build-up under crowns
Composite inlays
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051867 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051867: Grandio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051867
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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