510(k) · Cleared
ClearedFiltek Bulk Fill Flowable Restorative
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe Dental Products · EBF Material, Tooth Shade, Resin
Cleared on Mar 19, 2012 as substantially equivalent to K100235 (3M Company, 2010) and 3 other predicates after a 34-day review. Its family tree reaches back 3 generations to 1994. 8 later devices descend from it.
- Decided
- Mar 19, 2012
- Review
- 34 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K940459 (1994). 7 ancestors in all. 8 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK940459 Multipurpose Resin Cement with Fluoride (MRCF)Dentsply Intl. · 1994
- 2 generations backK981965 Flowable CompositeDentsply Intl. · 1998
- 1 generation backK083841 Adaptable Composite Resin Restorative MaterialDentsply International, Inc. · 2009
- This deviceK120453 Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012
- Descendant · cites it directly · 2 of its ownK182714 Novidia Bulk Fill Flow CompositeNobio, Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK201010 Infinix Universal Composite, Infinix Flowable Composite, Infinix…Nobio, Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK253513 MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025
- Descendant · cites it directly · 0 of its ownK242713 Any-Com BulkMediclus Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242014 Jet Flow BulkMeta Biomed Co., Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182714Novidia Bulk Fill Flow CompositeNobio, Ltd. · 2019 · cites it directly2descendants
- K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeNobio, Ltd. · 2020 · 2 generations on1descendant
- K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025 · 3 generations on0descendants
- K242713Any-Com BulkMediclus Co., Ltd. · 2025 · cites it directly0descendants
- K242014Jet Flow BulkMeta Biomed Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940459 | Multipurpose Resin Cement with Fluoride (MRCF) | Dentsply Intl. | 1994 | — |
| −2 | K981965 | Flowable Composite | Dentsply Intl. | 1998 | — |
| −1 | K083841 | Adaptable Composite Resin Restorative Material | Dentsply International, Inc. | 2009 | — |
| 0 (this device) | K120453 | Filtek Bulk Fill Flowable Restorative | 3M Espe Dental Products | 2012 | — |
| +1 | K182714 | Novidia Bulk Fill Flow Composite | Nobio, Ltd. | 2019 | — |
| +2 | K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill… | Nobio, Ltd. | 2020 | — |
| +3 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | 2025 | — |
| +1 | K242713 | Any-Com Bulk | Mediclus Co., Ltd. | 2025 | — |
| +1 | K242014 | Jet Flow Bulk | Meta Biomed Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K100235 | Filtek Supreme Ultra Flowable RestorativeSummary page 1…Product Code: EBF) Predicate Devices: Filtekim Supreme Ultra Flowable Restorative (K100235) Adaptable Composite Resin Restorative Material (K083841) RevolutionTM Formula 2 (K013647)… | 2010 |
| * | K083841 | Adaptable Composite Resin Restorative MaterialSummary page 1…Predicate Devices: Filtekim Supreme Ultra Flowable Restorative (K100235) Adaptable Composite Resin Restorative Material (K083841) RevolutionTM Formula 2 (K013647) 3MTM Dent I1System (K981647) Filtekm Bulk Fill Flowable R… | 2009 |
| * | K013647 | Revolution Formula 2Summary page 1…Filtekim Supreme Ultra Flowable Restorative (K100235) Adaptable Composite Resin Restorative Material (K083841) RevolutionTM Formula 2 (K013647) 3MTM Dent I1System (K981647) Filtekm Bulk Fill Flowable Restorative 5 10(k)… | 2002 |
| * | K981647 | 3M Dent II SystemSummary page 1…K100235) Adaptable Composite Resin Restorative Material (K083841) RevolutionTM Formula 2 (K013647) 3MTM Dent I1System (K981647) Filtekm Bulk Fill Flowable Restorative 5 10(k) Page 7 of 150 3M ESPE… | 1998 |
What descends from it? (8)
6 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 18 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K182714 (Nobio, Ltd., 2019) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K100235.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
*Base under Class I and 11 direct restorations
*Liner under direct restorative materials
*Pit and fissure sealant
*Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
*Class III and V restorations
*Undercut blockout
*Repair of small enamel defects
Repair of small defects in esthetic indirect restorations
*Repair of resin and acrylic temporary materials
*As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120453 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120453: Filtek Bulk Fill Flowable Restorative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120453
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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