510(k) · Cleared
ClearedQuixx Posterior Restorative
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International · EBF Material, Tooth Shade, Resin
Cleared on Apr 1, 2004 as substantially equivalent to K973235 (Dentsply Intl., 1998) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Apr 1, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950991 (1995). 5 ancestors in all, the oldest K863092 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK950991 Dyract II RestorativeDentsply Intl. · 1995
- 1 generation backK973235 Dyract AP RestorativeDentsply Intl. · 1998
- This deviceK040144 Quixx Posterior RestorativeDentsply International · 2004
- Descendant · cites it directly · 0 of its ownK053391 X-Tra FilVoco GmbH · 2006
- Descendant · cites it directly · 0 of its ownK050880 Dyract Extra RestorativeDentsply Intl. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950991 | Dyract II Restorative | Dentsply Intl. | 1995 | — |
| −1 | K973235 | Dyract AP Restorative | Dentsply Intl. | 1998 | — |
| 0 (this device) | K040144 | Quixx Posterior Restorative | Dentsply International | 2004 | — |
| +1 | K053391 | X-Tra Fil | Voco GmbH | 2006 | — |
| +1 | K050880 | Dyract Extra Restorative | Dentsply Intl. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K973235 | Dyract AP RestorativeSummary page 1…ORATIVE CLASSIFICATION NAME: Tooth shade resin material (872.3690 PREDICATE DEVICES: Dvractjk AP RestoratiVe K973235 5 , Posterior Restorative Surel'ilV… | 1998 |
| * | K973221 | Composite 168 Restorative SystemSummary page 1…lass I and II cav'ities. TECHNOLOGICAL CHARACTTERISTICS: All of the components of Qt'IXXT 1N POSTFRIOR RESTORATIVE are found in the legally marketed predicate devices. K973221 and K973235. QUIXXTM POSTERIOR RESTORATIVE was tested for cvtotoxicitv and mnutattenicitv and found to be non-cytotoxic and non-… | 1998 |
What descends from it? (2)
2 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K053391 (Voco GmbH, 2006) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K973235.
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?
Indicated for posterior Class I and II cavities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040144: Quixx Posterior Restorative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040144
Report an extraction error
Are you the manufacturer?
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