510(k) · Cleared
ClearedNovidia Flowable 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 3, 2019 as substantially equivalent to K100235 (3M Company, 2010) after a 287-day review. Its family tree reaches back 1 generation to 2010. 3 later devices descend from it.
- Decided
- Jul 3, 2019
- Review
- 287 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K100235 (2010). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK100235 Filtek Supreme Ultra Flowable Restorative3M Company · 2010
- This deviceK182580 Novidia Flowable CompositeNobio, Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK182921 Infinix Universal 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 3 of 3 · See all- K182921Infinix Universal CompositeNobio, Ltd. · 2019 · cites it directly2descendants
- K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeNobio, Ltd. · 2020 · cites it directly1descendant
- K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K100235 | Filtek Supreme Ultra Flowable Restorative | 3M Company | 2010 | — |
| 0 (this device) | K182580 | Novidia Flowable Composite | Nobio, Ltd. | 2019 | — |
| +1 | K182921 | Infinix Universal 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K100235 | Filtek Supreme Ultra Flowable RestorativeSummary page 4…Class: 2 Review Panel: Dental 5.3 PREDICATE DEVICE Filtek Supreme Ultra Flowable Restorative, manufactured by 3M Company, cleared under K100235. Additionally, we are using the following reference devices as examples of FDA- cleared devices that incorporate quaternary ammon… | 2010 |
| † | K033938 | Clearfil Protect Bond | 2004 |
| † | K141439 | Orthodontic Acrylic (Not Finalized) | 2014 |
| † | K163482 | Orthodontic Acrylic 2 | 2017 |
What descends from it? (3)
2 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?
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?
The Novidia™ Flowable Composite is indicated for:
1. Class III and V restorations
2. Restoration of minimally invasive cavity preparations (including small, non-stress bearing occlusal restorations)
3. As base/liner under direct or indirect restorations
4. Repair of small defects in esthetic indirect restorations
5. Pit and fissure sealing
6. Blocking out of undercuts
7. Repair of resin and acrylic temporary materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182580: Novidia 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/K182580
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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