510(k) · Cleared
ClearedVisio-Gem Art-System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe GmbH (Us) · EBF Material, Tooth Shade, Resin
Cleared on Mar 29, 1991 after a 108-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 61 later devices descend from it.
- Decided
- Mar 29, 1991
- Review
- 108 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
61 later devices descend from it, 1 citing it directly.
- This deviceK905604 Visio-Gem Art-SystemEspe GmbH (Us) · 1991
- Descendant · cites it directly · 60 of its ownK973513 Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent…Espe GmbH & Co. Kg. · 1997
- Descendant · 2 generations on · 59 of its ownK992645 SinfonyEspe Dental AG · 1999
- Descendant · 3 generations on · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 4 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
- Descendant · 3 generations on · 12 of its ownK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K973513Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal,Sinfony Magic…Espe GmbH & Co. Kg. · 1997 · cites it directly60descendants
- K992645SinfonyEspe Dental AG · 1999 · 2 generations on59descendants
- K071131UNO3M Espe AG Dental Products · 2007 · 3 generations on35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 4 generations on34descendants
- K042929Estenia C&BKuraray Medical Kurashiki Plant · 2004 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905604 | Visio-Gem Art-System | Espe GmbH (Us) | 1991 | — |
| +1 | K973513 | Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent… | Espe GmbH & Co. Kg. | 1997 | — |
| +2 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| +3 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +4 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +3 | K042929 | Estenia C&B | Kuraray Medical Kurashiki Plant | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (61)
See all 611 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973513 | Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal,Sinfony Magic… | 1997 | 60 |
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?
- Of its descendants, K973513 (Espe GmbH & Co. Kg., 1997) has gone furthest, with 60 descendants 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 | — |
https://510kreport.com/device/K905604 · printed Nov 3, 2026
Cite this page
510(k) Report. “K905604: Visio-Gem Art-System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K905604
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026