510(k) · Cleared
ClearedEstelite Color
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 Apr 5, 2011 as substantially equivalent to K961284 (Sybron Dental Specialties, Inc., 1996) and 2 other predicates after a 74-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.
- Decided
- Apr 5, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K002863 (2001). 6 ancestors in all, the oldest K961284 (1996). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK002863 Palfique Estelite LVTokuyama America, Inc. · 2001
- 2 generations backK051808 Estelite Flow QuickTokuyama Dental Corporation · 2005
- 1 generation backK072746 E-1 Esthetic Composite SystemTokuyama Dental Corporation · 2007
- This deviceK110178 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
- Descendant · 2 generations on · 0 of its ownK180613 Estelite Universal FlowTokuyama Dental Corporation · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002863 | Palfique Estelite LV | Tokuyama America, Inc. | 2001 | — |
| −2 | K051808 | Estelite Flow Quick | Tokuyama Dental Corporation | 2005 | — |
| −1 | K072746 | E-1 Esthetic Composite System | Tokuyama Dental Corporation | 2007 | — |
| 0 (this device) | 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 | — |
| +2 | K180613 | Estelite Universal Flow | Tokuyama Dental Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K961284 | KOLOR + | 1996 |
| * | K072746 | E-1 Esthetic Composite SystemSummary page 2…r purposes of biocompatibility the device is substantially equivalent to Tokuyama's own E-lI ESTHETIC COMPOSITE SYSTEM tooth shade resin material (K#072746) and Tokuyama's own ESTELITE SIGMA QUICK tooth shade resin material (K#080940). 807.92(a)(4) ESTELITE COLOR is a… | 2007 |
| * | K080940 | Estelite Sigma QuickSummary page 2…ama's own E-lI ESTHETIC COMPOSITE SYSTEM tooth shade resin material (K#072746) and Tokuyama's own ESTELITE SIGMA QUICK tooth shade resin material (K#080940). 807.92(a)(4) ESTELITE COLOR is a low viscosity light-cured tint for individualized shade characterizations. Th… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161353 | ESTELITE BULK FILL Flow | 2017 | 2 |
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 10 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K161353 (Tokuyama Dental Corporation, 2017) has gone furthest, with 2 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. 2011, 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 ESTELITE COLOR tooth shade resin material is for masking discolorations and making individualized shade characterizations in direct and indirect resin restorations, applied below or in between layers of the composite restoration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110178: Estelite Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110178
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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