510(k) · Cleared
ClearedTargis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar North America, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Sep 25, 1996 after a 63-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 69 later devices descend from it.
- Decided
- Sep 25, 1996
- Review
- 63 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
69 later devices descend from it, 4 citing it directly.
- This deviceK962878 Targis SystemIvoclar North America, Inc. · 1996
- Descendant · cites it directly · 59 of its ownK992645 SinfonyEspe Dental AG · 1999
- Descendant · 2 generations on · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 3 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
- Descendant · cites it directly · 18 of its ownK982164 EsteniaKuraray America, Inc. · 1998
- Descendant · 2 generations on · 17 of its ownK012707 EsteniaKuraray Medical, Inc. · 2001
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K992645SinfonyEspe Dental AG · 1999 · cites it directly59descendants
- K071131UNO3M Espe AG Dental Products · 2007 · 2 generations on35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 3 generations on34descendants
- K982164EsteniaKuraray America, Inc. · 1998 · cites it directly18descendants
- K012707EsteniaKuraray Medical, Inc. · 2001 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962878 | Targis System | Ivoclar North America, Inc. | 1996 | — |
| +1 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| +2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +3 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +1 | K982164 | Estenia | Kuraray America, Inc. | 1998 | — |
| +2 | K012707 | Estenia | Kuraray Medical, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (69)
See all 694 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?
- Of its descendants, K992645 (Espe Dental AG, 1999) has gone furthest, with 59 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/K962878 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962878: Targis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962878
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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