510(k) · Cleared
ClearedChroma Zone Color Stain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Medical, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Sep 14, 2001 as substantially equivalent to K982259 (Kuraray America, Inc., 1998) after a 31-day review. Its family tree reaches back 2 generations to 1994. 14 later devices descend from it.
- Decided
- Sep 14, 2001
- Review
- 31 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940800 (1994). 7 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK940800 Dentacolor Vita (VS) Shade SystemHeraeus Kulzer, Inc. · 1994
- 1 generation backK982259 Chroma Zone Color StainKuraray America, Inc. · 1998
- This deviceK012737 Chroma Zone Color StainKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 12 of its ownK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
- Descendant · 2 generations on · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK063595 Clearfil Majesty PosteriorKuraray America, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K042929Estenia C&BKuraray Medical Kurashiki Plant · 2004 · cites it directly12descendants
- K111982Clearfil DC Core PlusKuraray America, Inc. · 2011 · 2 generations on6descendants
- K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · 3 generations on4descendants
- K063595Clearfil Majesty PosteriorKuraray America, Inc. · 2007 · 2 generations on4descendants
- K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc. · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940800 | Dentacolor Vita (VS) Shade System | Heraeus Kulzer, Inc. | 1994 | — |
| −1 | K982259 | Chroma Zone Color Stain | Kuraray America, Inc. | 1998 | — |
| 0 (this device) | K012737 | Chroma Zone Color Stain | Kuraray Medical, Inc. | 2001 | — |
| +1 | K042929 | Estenia C&B | Kuraray Medical Kurashiki Plant | 2004 | — |
| +2 | K111982 | Clearfil DC Core Plus | Kuraray America, Inc. | 2011 | — |
| +3 | K142625 | PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value… | Kuraray Noritake Dental, Inc. | 2015 | — |
| +2 | K063595 | Clearfil Majesty Posterior | Kuraray America, Inc. | 2007 | — |
| +2 | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory… | Kuraray Noritake Dental, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 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? (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 |
|---|---|---|---|
| * | K982259 | Chroma Zone Color StainSummary page 1…is to alter the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. CHROMA ZONE COLOR STAIN by Kuraray Co., Ltd. (K982259) 4. Description for the premarket notification CHROMA ZONE COLOR STAIN is classified into tooth shade resin material, CFR 21 Sec… | 1998 |
What descends from it? (14)
See all 142 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 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K042929 (Kuraray Medical Kurashiki Plant, 2004) has gone furthest, with 12 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.
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?
CHROMA ZONE COLOR STAIN is designed to be used for developing color characterization for resin-based:
1) Facing crown
2) Jacket crown
3) Inlay and Onlay
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/K012737 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012737: Chroma Zone Color Stain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012737
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026