510(k) · Cleared
ClearedOmnichroma Flow Bulk
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 Feb 3, 2021 as substantially equivalent to K161353 (Tokuyama Dental Corporation, 2017) and 1 other predicate after a 56-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Feb 3, 2021
- Review
- 56 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002863 (2001). 12 ancestors in all, the oldest K961284 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK002863 Palfique Estelite LVTokuyama America, Inc. · 2001
- 4 generations backK051808 Estelite Flow QuickTokuyama Dental Corporation · 2005
- 3 generations backK072746 E-1 Esthetic Composite SystemTokuyama Dental Corporation · 2007
- 2 generations backK110178 Estelite ColorTokuyama Dental Corporation · 2011
- 1 generation backK161353 ESTELITE BULK FILL FlowTokuyama Dental Corporation · 2017
- This deviceK203598 Omnichroma Flow BulkTokuyama Dental Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002863 | Palfique Estelite LV | Tokuyama America, Inc. | 2001 | — |
| −4 | K051808 | Estelite Flow Quick | Tokuyama Dental Corporation | 2005 | — |
| −3 | 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 | — |
| 0 (this device) | K203598 | Omnichroma Flow Bulk | Tokuyama Dental Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K161353 | ESTELITE BULK FILL FlowSummary page 6…Tokuyama Dental Tokuyama Dental Tokuyama Dental - 510(k) No. K203598 K161353 K193537 - Health Canada licence No. (Pending) 98095… | 2017 |
| * | K193537 | Omnichroma FlowSummary page 6…Dental Tokuyama Dental Tokuyama Dental - 510(k) No. K203598 K161353 K193537 - Health Canada licence No. (Pending) 98095 104170 Classifica… | 2020 |
| † | K180613 | Estelite Universal Flow | 2018 |
| † | K173275 | Omnichroma | 2018 |
| † | K051808 | Estelite Flow Quick | 2005 |
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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K161353.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 material in dental procedures such as:
- Direct anterior and posterior restorations
- Cavity base or liner
- Blocking out cavity undercuts before fabricating indirect restorations
- Repair of porcelain/composite
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203598 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203598: Omnichroma Flow Bulk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203598
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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