510(k) · Cleared
ClearedEstelite Flow Quick
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tokuyama Dental Corporation · EBF Material, Tooth Shade, Resin
Cleared on Aug 8, 2005 as substantially equivalent to K002863 (Tokuyama America, Inc., 2001) after a 34-day review. Its family tree reaches back 1 generation to 2001. 8 later devices descend from it.
- Decided
- Aug 8, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002863 (2001). 8 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK002863 Palfique Estelite LVTokuyama America, Inc. · 2001
- This deviceK051808 Estelite Flow QuickTokuyama Dental Corporation · 2005
- Descendant · cites it directly · 5 of its ownK080940 Estelite Sigma QuickTokuyama Dental Corporation · 2008
- Descendant · cites it directly · 4 of its ownK072746 E-1 Esthetic Composite SystemTokuyama Dental Corporation · 2007
- Descendant · 2 generations on · 3 of its ownK110178 Estelite ColorTokuyama Dental Corporation · 2011
- Descendant · cites it directly · 2 of its ownK161353 ESTELITE BULK FILL FlowTokuyama Dental Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK203598 Omnichroma Flow BulkTokuyama Dental Corporation · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K080940Estelite Sigma QuickTokuyama Dental Corporation · 2008 · cites it directly5descendants
- K072746E-1 Esthetic Composite SystemTokuyama Dental Corporation · 2007 · cites it directly4descendants
- K110178Estelite ColorTokuyama Dental Corporation · 2011 · 2 generations on3descendants
- K161353ESTELITE BULK FILL FlowTokuyama Dental Corporation · 2017 · cites it directly2descendants
- K203598Omnichroma Flow BulkTokuyama Dental Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002863 | Palfique Estelite LV | Tokuyama America, Inc. | 2001 | — |
| 0 (this device) | K051808 | Estelite Flow Quick | Tokuyama Dental Corporation | 2005 | — |
| +1 | K080940 | Estelite Sigma Quick | Tokuyama Dental Corporation | 2008 | — |
| +1 | K072746 | E-1 Esthetic Composite System | Tokuyama Dental Corporation | 2007 | — |
| +2 | K110178 | Estelite Color | Tokuyama Dental Corporation | 2011 | — |
| +1 | K161353 | ESTELITE BULK FILL Flow | Tokuyama Dental Corporation | 2017 | — |
| +2 | K203598 | Omnichroma Flow Bulk | Tokuyama Dental Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K002863 | Palfique Estelite LVSummary page 2…ological Characteristics and Substantial Equivalence The chemical structure of ESTELITE FLOW QUICK is nearly identical to that of Tokuyama's own PALFIQUE ESTELITE LV (K#002863). The only change is a slight modification to the formula by adding three new chemicals, each of which comprising more than 0.1%… | 2001 |
What descends from it? (8)
4 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?
- Its one ancestor has no recall.
- Of its descendants, K080940 (Tokuyama Dental Corporation, 2008) has gone furthest, with 5 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.
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?
For use as a tooth shade resin material in dental procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051808 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051808: Estelite Flow Quick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051808
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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