510(k) · Cleared
ClearedFusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prevest Denpro Limited · EBF Material, Tooth Shade, Resin
Cleared on Jan 5, 2024 as substantially equivalent to K201707 (Dentscare Ltda, 2020) and 3 other predicates after a 248-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Jan 5, 2024
- Review
- 248 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K031877 (2003). 10 ancestors in all, the oldest K993783 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK031877 Embrace Wet-Bond Restorative MaterialPulpdent Corporation · 2003
- 2 generations backK072545 Artiste SE Flowable Composite, Model N280Pentron Clinical Technologies · 2007 · Recalled
- 1 generation backK102603 SA Flowable AdhesiveDmg USA, Inc. · 2010
- This deviceK231263 Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTPrevest Denpro Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031877 | Embrace Wet-Bond Restorative Material | Pulpdent Corporation | 2003 | — |
| −2 | K072545 | Artiste SE Flowable Composite, Model N280 | Pentron Clinical Technologies | 2007 | 1 |
| −1 | K102603 | SA Flowable Adhesive | Dmg USA, Inc. | 2010 | — |
| 0 (this device) | K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | Prevest Denpro Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 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? (4)
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 |
|---|---|---|---|
| * | K201707 | Opallis, Opallis FlowSummary page 7…SO 4049:2019. The predicate and reference devices use the same ISO standard for their testing. Their shelf lives are 3 years or are not given. Predicate Device: Opallis K201707, Build-it Total Core K102703, Tetric Evoflow K993783, Constic K102603 Reference Devices: everX Posterior K153127, Cal LC K212457… | 2020 |
| * | K102703 | Build-IT Total CoreSummary page 7…nd reference devices use the same ISO standard for their testing. Their shelf lives are 3 years or are not given. Predicate Device: Opallis K201707, Build-it Total Core K102703, Tetric Evoflow K993783, Constic K102603 Reference Devices: everX Posterior K153127, Cal LC K212457, Tetric Evoceram K042819, Op… | 2011 |
| * | K993783 | Tetric FlowSummary page 7…the same ISO standard for their testing. Their shelf lives are 3 years or are not given. Predicate Device: Opallis K201707, Build-it Total Core K102703, Tetric Evoflow K993783, Constic K102603 Reference Devices: everX Posterior K153127, Cal LC K212457, Tetric Evoceram K042819, Opallis Flow K201707, Evad… | 1999 |
| * | K102603 | SA Flowable AdhesiveSummary page 7…ndard for their testing. Their shelf lives are 3 years or are not given. Predicate Device: Opallis K201707, Build-it Total Core K102703, Tetric Evoflow K993783, Constic K102603 Reference Devices: everX Posterior K153127, Cal LC K212457, Tetric Evoceram K042819, Opallis Flow K201707, Evadyne K111666 Subs… | 2010 |
| † | K153127 | everX Posterior | 2016 |
| † | K212457 | Cal LC | |
| † | K042819 | Tetric Evoceram | 2004 |
| † | K111666 | Evadyne Temporary Crown and Bridge Resin | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K201707.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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?
Fusion Core DC Flo is indicated for use as core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material, and as a dentin replacement material. Fusion Flo is indicated for direct filling of class V (cervical caries, root erosions, and wedge shaped defects), anterior restorations( Class III and IV), small posterior restorations, repair of composite/ceramic veneers, and blocking…
Read the full statement (144 words)
Fusion Core DC Flo is indicated for use as core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material, and as a dentin replacement material.
Fusion Flo is indicated for direct filling of class V (cervical caries, root erosions, and wedge shaped defects), anterior restorations( Class III and IV), small posterior restorations, repair of composite/ceramic veneers, and blocking out of undercuts.
Fusion Flo SE is indicated for direct filling of class V (cervical caries, root erosions, wedge shaped defects), anterior restorations (Class III and IV), small posterior restorations.
Fusion I-Seal is indicated for Class I and Class II restorations, as a liner under composite restorations, and as a pit and fissure sealant.
Magma NT is indicated for direct restoration in anterior and posterior teeth classes I, II, III, IV and V, and porcelain/composite repairs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231263 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231263: Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231263
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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