510(k) · Cleared
ClearedDyract II Restorative
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EBF Material, Tooth Shade, Resin
Cleared on Mar 23, 1995 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Mar 23, 1995
- Review
- 20 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK950991 Dyract II RestorativeDentsply Intl. · 1995
- Descendant · cites it directly · 10 of its ownK973235 Dyract AP RestorativeDentsply Intl. · 1998
- Descendant · 2 generations on · 3 of its ownK982395 Dytract Flow RestorativeDentsply Intl. · 1998
- Descendant · 2 generations on · 2 of its ownK040144 Quixx Posterior RestorativeDentsply International · 2004
- Descendant · 2 generations on · 1 of its ownK994056 AdmiraVoco GmbH · 2000
- Descendant · 3 generations on · 0 of its ownK053391 X-Tra FilVoco GmbH · 2006
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K973235Dyract AP RestorativeDentsply Intl. · 1998 · cites it directly10descendants
- K982395Dytract Flow RestorativeDentsply Intl. · 1998 · 2 generations on3descendants
- K040144Quixx Posterior RestorativeDentsply International · 2004 · 2 generations on2descendants
- K994056AdmiraVoco GmbH · 2000 · 2 generations on1descendant
- K053391X-Tra FilVoco GmbH · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950991 | Dyract II Restorative | Dentsply Intl. | 1995 | — |
| +1 | K973235 | Dyract AP Restorative | Dentsply Intl. | 1998 | — |
| +2 | K982395 | Dytract Flow Restorative | Dentsply Intl. | 1998 | — |
| +2 | K040144 | Quixx Posterior Restorative | Dentsply International | 2004 | — |
| +2 | K994056 | Admira | Voco GmbH | 2000 | — |
| +3 | K053391 | X-Tra Fil | Voco GmbH | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 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? (12)
See all 122 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, K973235 (Dentsply Intl., 1998) has gone furthest, with 10 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/K950991 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950991: Dyract II Restorative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950991
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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