510(k) · Cleared
ClearedBulk Fill Flowable Composite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novocol, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Nov 14, 2014 as substantially equivalent to K091635 (Heraeus Kulzer, LLC, 2009) and 2 other predicates after a 115-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Nov 14, 2014
- Review
- 115 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K940459 (1994). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK940459 Multipurpose Resin Cement with Fluoride (MRCF)Dentsply Intl. · 1994
- 3 generations backK981965 Flowable CompositeDentsply Intl. · 1998
- 2 generations backK083841 Adaptable Composite Resin Restorative MaterialDentsply International, Inc. · 2009
- 1 generation backK120453 Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012
- This deviceK141994 Bulk Fill Flowable CompositeNovocol, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940459 | Multipurpose Resin Cement with Fluoride (MRCF) | Dentsply Intl. | 1994 | — |
| −3 | K981965 | Flowable Composite | Dentsply Intl. | 1998 | — |
| −2 | K083841 | Adaptable Composite Resin Restorative Material | Dentsply International, Inc. | 2009 | — |
| −1 | K120453 | Filtek Bulk Fill Flowable Restorative | 3M Espe Dental Products | 2012 | — |
| 0 (this device) | K141994 | Bulk Fill Flowable Composite | Novocol, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K091635 | Venus Diamond FlowSummary page 4…Material, Tooth Shade, Resin Predicate Devices: 510(k)# Product Manufacturer K091635 Venus Diamond Flow Heraeus Kulzer Filtek Bulk Fill Flowable… | 2009 |
| * | K120453 | Filtek Bulk Fill Flowable RestorativeSummary page 4…Manufacturer K091635 Venus Diamond Flow Heraeus Kulzer Filtek Bulk Fill Flowable K120453 3M ESPE Restorative K123773 X-Tra B… | 2012 |
| * | K123773 | X-Tra BaseSummary page 4…Filtek Bulk Fill Flowable K120453 3M ESPE Restorative K123773 X-Tra Base VOCO (GmbH) Device Description: The new Bulk Fill Flowable Composite manufactu… | 2012 |
| † | K072150 | Dimer Acid Derived Nano-Hybrid Composite Restorative Material | 2007 |
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 20 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 2 other devices also cite its predicate K091635.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 II direct restorations
Liner under direct restorative materials
Class III and V restorations
Undercut Blockout
Minimally invasive cavities (including small non stress-bearing occlusal restorations)
Tunnel preparations
Repair of small enamel defects
Repair of small defects in esthetic indirect restorations
Repair of resin and acrylic temporary materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141994: Bulk Fill Flowable Composite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141994
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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