510(k) · Cleared
ClearedInfinix Universal 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 Sep 13, 2019 as substantially equivalent to K042819 (Ivoclar Vivadent, Inc., 2004) and 1 other predicate after a 329-day review. Its family tree reaches back 2 generations to 2010. 2 later devices descend from it.
- Decided
- Sep 13, 2019
- Review
- 329 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K100235 (2010). 3 ancestors in all, the oldest K042819 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK100235 Filtek Supreme Ultra Flowable Restorative3M Company · 2010
- 1 generation backK182580 Novidia Flowable CompositeNobio, Ltd. · 2019
- This deviceK182921 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K100235 | Filtek Supreme Ultra Flowable Restorative | 3M Company | 2010 | — |
| −1 | K182580 | Novidia Flowable Composite | Nobio, Ltd. | 2019 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (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 |
|---|---|---|---|
| * | K042819 | Tetric EvoceramSummary page 4…2.3690 Class: 2 Review Panel: Dental 5.3 PREDICATE DEVICE Tetric EvoCeram®, manufactured by Ivoclar Vivadent, cleared under K042819 is the primary predicate device. Additionally, we are using the following reference devices as examples of FDA- cleared devices t… | 2004 |
| * | K182580 | Novidia Flowable Composite Cleared while this submission was under review Summary page 4…wing reference devices as examples of FDA- cleared devices that incorporate quaternary ammonium in their formulation: • Infinix™ Flowable Composite cleared under K182580. • Clearfil Protect Bond cleared under K033938 • Orthodontic Acrylic cleared under K141439 and Orthodontic Acryli… | 2019 |
| † | 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 9 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K201010 (Nobio, Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K042819.
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 Infinix™ Universal Composite is indicated for:
• Restorations in the posterior region (Class I and II)
• Anterior restorations (Class III, IV)
• Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• Veneering of discolored anterior teeth
• Splinting of mobile teeth
• Extended fissure sealing in molars and premolars
• Repair of composite/ceramic veneers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182921: Infinix Universal Composite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182921
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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