510(k) · Cleared
ClearedInfinix Universal Composite, Infinix Flowable Composite, Infinix 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 Aug 14, 2020 as substantially equivalent to K182921 (Nobio, Ltd., 2019) and 2 other predicates after a 119-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Aug 14, 2020
- Review
- 119 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K940459 (1994). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK940459 Multipurpose Resin Cement with Fluoride (MRCF)Dentsply Intl. · 1994
- 4 generations backK981965 Flowable CompositeDentsply Intl. · 1998
- 3 generations backK083841 Adaptable Composite Resin Restorative MaterialDentsply International, Inc. · 2009
- 2 generations backK120453 Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012
- 1 generation backK182714 Novidia Bulk Fill Flow CompositeNobio, Ltd. · 2019
- This deviceK201010 Infinix Universal Composite, Infinix Flowable Composite, Infinix…Nobio, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK253513 MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025
Most influential descendants
Showing 1 of 1 · See all- K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940459 | Multipurpose Resin Cement with Fluoride (MRCF) | Dentsply Intl. | 1994 | — |
| −4 | K981965 | Flowable Composite | Dentsply Intl. | 1998 | — |
| −3 | K083841 | Adaptable Composite Resin Restorative Material | Dentsply International, Inc. | 2009 | — |
| −2 | K120453 | Filtek Bulk Fill Flowable Restorative | 3M Espe Dental Products | 2012 | — |
| −1 | K182714 | Novidia Bulk Fill Flow Composite | Nobio, Ltd. | 2019 | — |
| 0 (this device) | K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill… | Nobio, Ltd. | 2020 | — |
| +1 | 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 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K182921 | Infinix Universal CompositeSummary page 6…Product Code: EBF Regulation No: 872.3690 Class: 2 Review Panel: Dental 5.3 PREDICATE DEVICES • K182921 Infinix™ Universal Composite (previously called Novidia™ Universal Composite)… | 2019 |
| * | K182580 | Novidia Flowable CompositeSummary page 7…Page 1 of 5 Infinix™ Family of Dental Composites – Section 5 • K182580 Infinix™ Flowable Composite (previously called Novidia™ Flowable Composite) • K182714 Infinix™ Bulk Fill Flow Composite… | 2019 |
| * | K182714 | Novidia Bulk Fill Flow CompositeSummary page 7…Infinix™ Family of Dental Composites – Section 5 • K182580 Infinix™ Flowable Composite (previously called Novidia™ Flowable Composite) • K182714 Infinix™ Bulk Fill Flow Composite (previously called Novidia™ Bulk Fill Flow Composite) 5.4 DEVICE DESCRIPTION Compo… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | 2025 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K253513 (Premier Dental Products Company, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
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 The addition of the QASi particles to the Infinix™ Universal Composite reduces demineralization, which is part of the caries-formation…
Read the full statement (229 words)
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
The addition of the QASi particles to the Infinix™ Universal Composite reduces demineralization, which is part of the caries-formation process.
Class III and V restorations
Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
As base/liner under direct or indirect restorations
Repair of small defects in aesthetic indirect restorations
Pit and fissure sealant
Blocking out of undercuts
Repair of resin and acrylic temporary materials
The addition of the QASi particles to the Infinix™ Flowable Composite reduces demineralization, which is part of the caries-formation process.
Base under Class I and II 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
Blocking out of undercuts
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
The addition of the QASi particles to the Infinix™ Bulk Fill Flow Composite reduces demineralization, which is part of the caries-formation process.
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/K201010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201010: Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201010
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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