510(k) · Cleared
ClearedNovidia Bulk Fill Flow Composite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobio, Ltd. · EBF Material, Tooth Shade, Resin
Cleared on Jul 12, 2019 as substantially equivalent to K120453 (3M Espe Dental Products, 2012) after a 288-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 12, 2019
- Review
- 288 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940459 (1994). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- 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 deviceK182714 Novidia Bulk Fill Flow CompositeNobio, Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK201010 Infinix Universal Composite, Infinix Flowable Composite, Infinix…Nobio, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK253513 MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025
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 |
|---|---|---|---|---|---|
| −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) | K182714 | Novidia Bulk Fill Flow Composite | Nobio, Ltd. | 2019 | — |
| +1 | K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill… | Nobio, Ltd. | 2020 | — |
| +2 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | 2025 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K120453 | Filtek Bulk Fill Flowable RestorativeSummary page 4…Class: 2 Review Panel: Dental 5.3 PREDICATE DEVICE Filtek Bulk Fill Flowable Restorative, manufactured by 3M ESPE Dental Products, cleared under K120453 is the primary predicate device. Additionally, we are using the following reference devices as examples of FDA- cleared devices… | 2012 |
| † | K033938 | Clearfil Protect Bond | 2004 |
| † | K141439 | Orthodontic Acrylic (Not Finalized) | 2014 |
| † | K163482 | Orthodontic Acrylic 2 | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite | 2020 | 1 |
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 25 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K201010 (Nobio, Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K120453.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Novidia™ Bulk Fill Flow Composite is indicated for:
1. Base under Class I and II direct restorations
2. Liner under direct restorative materials
3. Pit and fissure sealant
4. Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
5. Class III and V restorations
6. Blocking out of undercuts
7. Repair of small enamel defects
8. Repair of small defects in esthetic indirect restorations
9. Repair of resin and acrylic temporary materials
10. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182714 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182714: Novidia Bulk Fill Flow Composite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182714
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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