510(k) · Cleared
ClearedFiltek Supreme Ultra Flowable Restorative
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · EBF Material, Tooth Shade, Resin
Cleared on May 12, 2010 after a 106-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.
- Decided
- May 12, 2010
- Review
- 106 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 9 citing it directly.
- This deviceK100235 Filtek Supreme Ultra Flowable Restorative3M Company · 2010
- Descendant · cites it directly · 8 of its ownK120453 Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012
- Descendant · cites it directly · 3 of its ownK182580 Novidia Flowable CompositeNobio, Ltd. · 2019
- Descendant · 2 generations on · 2 of its ownK182921 Infinix Universal CompositeNobio, Ltd. · 2019
- Descendant · 2 generations on · 2 of its ownK182714 Novidia Bulk Fill Flow CompositeNobio, Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK213339 DENU Composite Resin, DENU Flow ResinHdi, Inc. · 2022
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K120453Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012 · cites it directly8descendants
- K182580Novidia Flowable CompositeNobio, Ltd. · 2019 · cites it directly3descendants
- K182921Infinix Universal CompositeNobio, Ltd. · 2019 · 2 generations on2descendants
- K182714Novidia Bulk Fill Flow CompositeNobio, Ltd. · 2019 · 2 generations on2descendants
- K213339DENU Composite Resin, DENU Flow ResinHdi, Inc. · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100235 | Filtek Supreme Ultra Flowable Restorative | 3M Company | 2010 | — |
| +1 | K120453 | Filtek Bulk Fill Flowable Restorative | 3M Espe Dental Products | 2012 | — |
| +1 | K182580 | Novidia Flowable Composite | Nobio, Ltd. | 2019 | — |
| +2 | K182921 | Infinix Universal Composite | Nobio, Ltd. | 2019 | — |
| +2 | K182714 | Novidia Bulk Fill Flow Composite | Nobio, Ltd. | 2019 | — |
| +1 | K213339 | DENU Composite Resin, DENU Flow Resin | Hdi, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | 3M LVR System Named without a submission number | |
| * | — | Revolution Formula 2 Named without a submission number |
What descends from it? (21)
See all 219 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120453 | Filtek Bulk Fill Flowable Restorative | 2012 | 8 |
| K182580 | Novidia Flowable Composite | 2019 | 3 |
| K213339 | DENU Composite Resin, DENU Flow Resin | 2022 | 1 |
| K221695 | 3M Filtek Supreme Flowable Restorative | 2022 | 1 |
| K103190 | Profil Composites (Profil, Profil Flow) | 2011 | 1 |
| K221510 | TrusFIL-Flow Flowable Composite Restorative | 2022 | 0 |
| K180463 | Apoller Flow Light Cure Flowable Composite | 2018 | 0 |
| K150623 | Nanova Flowable Composite | 2015 | 0 |
| K130672 | Optiflow II Flowable Composite, LC | 2013 | 0 |
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, K120453 (3M Espe Dental Products, 2012) has gone furthest, with 8 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. 2010, 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?
Class III and V restorations
Restoration of minimally invasive cavity preparations (including small, non stress-bearing occiusal restorations)
Base/liner under direct restorations
Repair of small defects in esthetic indirect restorations
Pit and fissure sealant
Undercut blockout
Repair of resin and acrylic temporary materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100235: Filtek Supreme Ultra Flowable Restorative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100235
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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