510(k) · Cleared
ClearedEstelite Sigma 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 Jun 19, 2008 as substantially equivalent to K980051 (Tokuyama America, Inc., 1998) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 2001. 5 later devices descend from it.
- Decided
- Jun 19, 2008
- Review
- 77 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002863 (2001). 3 ancestors in all, the oldest K980051 (1998). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002863 Palfique Estelite LVTokuyama America, Inc. · 2001
- 1 generation backK051808 Estelite Flow QuickTokuyama Dental Corporation · 2005
- This deviceK080940 Estelite Sigma QuickTokuyama Dental Corporation · 2008
- Descendant · cites it directly · 3 of its ownK110178 Estelite ColorTokuyama Dental Corporation · 2011
- Descendant · 2 generations on · 2 of its ownK161353 ESTELITE BULK FILL FlowTokuyama Dental Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK203598 Omnichroma Flow BulkTokuyama Dental Corporation · 2021
- Descendant · 3 generations on · 0 of its ownK180613 Estelite Universal FlowTokuyama Dental Corporation · 2018
- Descendant · cites it directly · 0 of its ownK110428 ESCOM 100Spident Co., Ltd. · 2011
Most influential descendants
Showing 5 of 5 · See all- K110178Estelite ColorTokuyama Dental Corporation · 2011 · cites it directly3descendants
- K161353ESTELITE BULK FILL FlowTokuyama Dental Corporation · 2017 · 2 generations on2descendants
- K203598Omnichroma Flow BulkTokuyama Dental Corporation · 2021 · 3 generations on0descendants
- K180613Estelite Universal FlowTokuyama Dental Corporation · 2018 · 3 generations on0descendants
- K110428ESCOM 100Spident Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002863 | Palfique Estelite LV | Tokuyama America, Inc. | 2001 | — |
| −1 | K051808 | Estelite Flow Quick | Tokuyama Dental Corporation | 2005 | — |
| 0 (this device) | K080940 | Estelite Sigma Quick | Tokuyama Dental Corporation | 2008 | — |
| +1 | K110178 | Estelite Color | Tokuyama Dental Corporation | 2011 | — |
| +2 | K161353 | ESTELITE BULK FILL Flow | Tokuyama Dental Corporation | 2017 | — |
| +3 | K203598 | Omnichroma Flow Bulk | Tokuyama Dental Corporation | 2021 | — |
| +3 | K180613 | Estelite Universal Flow | Tokuyama Dental Corporation | 2018 | — |
| +1 | K110428 | ESCOM 100 | Spident Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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? (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 |
|---|---|---|---|
| * | K980051 | Palfique Estelite PasteSummary page 2…cal Characteristics and Substantial Equivalence The chemical structure of ESTELITE SIGMA QUICK is nearly identical to Tokuyama's own ESTELITE SIGMA (a modification of K#980051) and ESTELITE FLOW QUICK (K#051808). ESTELITE SIGMA QUICK is formulated to shorten the curing time of the resin material compared… | 1998 |
| * | K051808 | Estelite Flow QuickSummary page 2…Equivalence The chemical structure of ESTELITE SIGMA QUICK is nearly identical to Tokuyama's own ESTELITE SIGMA (a modification of K#980051) and ESTELITE FLOW QUICK (K#051808). ESTELITE SIGMA QUICK is formulated to shorten the curing time of the resin material compared to ESTELITE SIGMA. The ESTELITE S… | 2005 |
What descends from it? (5)
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K110178 (Tokuyama Dental Corporation, 2011) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K980051.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
For use as a tooth shade resin in dental procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080940 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080940: Estelite Sigma Quick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080940
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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