510(k) · Cleared
ClearedESTELITE BULK FILL Flow
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 3, 2017 as substantially equivalent to K051808 (Tokuyama Dental Corporation, 2005) and 2 other predicates after a 322-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it.
- Decided
- Apr 3, 2017
- Review
- 322 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K002863 (2001). 8 ancestors in all, the oldest K961284 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK002863 Palfique Estelite LVTokuyama America, Inc. · 2001
- 3 generations backK051808 Estelite Flow QuickTokuyama Dental Corporation · 2005
- 2 generations backK072746 E-1 Esthetic Composite SystemTokuyama Dental Corporation · 2007
- 1 generation backK110178 Estelite ColorTokuyama Dental Corporation · 2011
- This deviceK161353 ESTELITE BULK FILL FlowTokuyama Dental Corporation · 2017
- Descendant · cites it directly · 0 of its ownK203598 Omnichroma Flow BulkTokuyama Dental Corporation · 2021
- Descendant · cites it directly · 0 of its ownK180613 Estelite Universal FlowTokuyama Dental Corporation · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002863 | Palfique Estelite LV | Tokuyama America, Inc. | 2001 | — |
| −3 | K051808 | Estelite Flow Quick | Tokuyama Dental Corporation | 2005 | — |
| −2 | K072746 | E-1 Esthetic Composite System | Tokuyama Dental Corporation | 2007 | — |
| −1 | K110178 | Estelite Color | Tokuyama Dental Corporation | 2011 | — |
| 0 (this device) | K161353 | ESTELITE BULK FILL Flow | Tokuyama Dental Corporation | 2017 | — |
| +1 | K203598 | Omnichroma Flow Bulk | Tokuyama Dental Corporation | 2021 | — |
| +1 | 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 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K051808 | Estelite Flow QuickSummary page 5…tics for obtaining FDA marketing authorization, the ESTELITE BULK FILL Flow device is substantially equivalent to Tokuyama’s own primary predicate ESTELITE FLOW QUICK (K#051808), as shown below: Device name ESTELITE BULK FILL Flow ESTELITE FLOW QUICK Sensitivity to ambient light Upon visual inspecti… | 2005 |
| * | K070215 | Tokuyama Bond ForceSummary page 8…BOI[IS - TeTIT For purposes of biocompatibility, the ESTELITE BULK FILL Flow device is substantially equivalent to Tokuyama’s own TOKUYAMA BOND FORCE (K#070215), ESTELITE FLOW QUICK (K#051808), and ESTELITE COLOR (K#110178), as all ingredients in the ESTELITE BULK FILL Flow device have be… | 2007 |
| * | K110178 | Estelite ColorSummary page 8…y, the ESTELITE BULK FILL Flow device is substantially equivalent to Tokuyama’s own TOKUYAMA BOND FORCE (K#070215), ESTELITE FLOW QUICK (K#051808), and ESTELITE COLOR (K#110178), as all ingredients in the ESTELITE BULK FILL Flow device have been cleared for marketing by the FDA for use in these similar de… | 2011 |
| † | K120453 | Filtek Bulk Fill Flowable Restorative | 2012 |
| † | K143679 | Nuance FLOW | 2015 |
What descends from it? (2)
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 16 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K203598 (Tokuyama Dental Corporation, 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K051808.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 lining
- Blocking out cavity undercuts before fabricating indirect restorations
- Repair of porcelain/composite
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/K161353 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161353: ESTELITE BULK FILL Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161353
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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