510(k) · Cleared
ClearedOmnichroma
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 27, 2018 as substantially equivalent to K010267 (Tokuyama America, Inc., 2001) after a 138-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Feb 27, 2018
- Review
- 138 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010267 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010267 Palfique Estelite LV ClearTokuyama America, Inc. · 2001
- This deviceK173275 OmnichromaTokuyama Dental Corporation · 2018
- Descendant · cites it directly · 1 of its ownK193537 Omnichroma FlowTokuyama Dental Corporation · 2020
- Descendant · cites it directly · 0 of its ownK261071 DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill…DiaDent Group International · 2026
- Descendant · 2 generations on · 0 of its ownK203598 Omnichroma Flow BulkTokuyama Dental Corporation · 2021
Most influential descendants
Showing 3 of 3 · See all- K193537Omnichroma FlowTokuyama Dental Corporation · 2020 · cites it directly1descendant
- K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…DiaDent Group International · 2026 · cites it directly0descendants
- 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 | K010267 | Palfique Estelite LV Clear | Tokuyama America, Inc. | 2001 | — |
| 0 (this device) | K173275 | Omnichroma | Tokuyama Dental Corporation | 2018 | — |
| +1 | K193537 | Omnichroma Flow | Tokuyama Dental Corporation | 2020 | — |
| +1 | K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL… | DiaDent Group International | 2026 | — |
| +2 | K203598 | Omnichroma Flow Bulk | Tokuyama Dental Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K010267 | Palfique Estelite LV ClearSummary page 6…- Manufacturer Tokuyama Dental Tokuyama Dental - 510(k) No. K173275 K010267 - Classification name Material, Tooth Shade, Material, Tooth Shade,… | 2001 |
| † | K121583 | Clearfil Majesty Flow | 2012 |
| † | K112501 | Venus Pearl PLT Refill A1 | 2011 |
| † | K080940 | Estelite Sigma Quick | 2008 |
| † | K051808 | Estelite Flow Quick | 2005 |
| † | K161353 | ESTELITE BULK FILL Flow | 2017 |
What descends from it? (3)
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?
- Its one ancestor has no recall.
- Of its descendants, K193537 (Tokuyama Dental Corporation, 2020) has gone furthest, with 1 descendant 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. 2018, 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
- Direct bonded composite veneer
- Diastema closure
- 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/K173275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173275: Omnichroma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173275
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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