510(k) · Cleared
ClearedApoller Flow Light Cure Flowable Composite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greenway Yw, LLC · EBF Material, Tooth Shade, Resin
Cleared on Nov 14, 2018 as substantially equivalent to K100235 (3M Company, 2010) after a 266-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Nov 14, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K100235 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK100235 Filtek Supreme Ultra Flowable Restorative3M Company · 2010
- This deviceK180463 Apoller Flow Light Cure Flowable CompositeGreenway Yw, LLC · 2018
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) | K180463 | Apoller Flow Light Cure Flowable Composite | Greenway Yw, LLC | 2018 | — |
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 5…evice Trade Name FiltekTM Supreme Ultra Flowable Restorative Common Name Tooth shade resin material 510 (k) Number K100235 Decision Date May 12, 2010 Manufacturer 3M Company Classification… | 2010 |
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?
- Its one ancestor has no recall.
- 8 other devices also cite its predicate K100235.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Class Il and V restorations
Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
Base/liner under direct restorations
Repair of small defects in esthetic indirect restorations
Pit and fissure sealant
Undercut blockout
Repair of resin and acrylic temporary materials
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/K180463 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180463: Apoller Flow Light Cure Flowable Composite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180463
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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