510(k) · Cleared
ClearedClearfil Majesty Esthetic
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 18, 2006 as substantially equivalent to K012740 (Kuraray Medical, Inc., 2001) and 3 other predicates after an 80-day review. Its family tree reaches back 2 generations to 1994. 11 later devices descend from it.
- Decided
- Sep 18, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K943168 (1994). 5 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK943168 Clearfil AP-XKuraray Company, Ltd. · 1994
- 1 generation backK012740 Clearfil AP-XKuraray Medical, Inc. · 2001
- This deviceK061860 Clearfil Majesty EstheticKuraray Medical, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK063595 Clearfil Majesty PosteriorKuraray America, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK121583 Clearfil Majesty FlowKuraray Noritake Dental, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK071169 Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK192178 R&D Series Nova Compo NImicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2019
- Descendant · 2 generations on · 0 of its ownK182430 Clearfil Majesty ICKuraray Noritake Dental, Inc. · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K063595Clearfil Majesty PosteriorKuraray America, Inc. · 2007 · cites it directly4descendants
- K121583Clearfil Majesty FlowKuraray Noritake Dental, Inc. · 2012 · cites it directly3descendants
- K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007 · 2 generations on1descendant
- K192178R&D Series Nova Compo NImicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2019 · cites it directly0descendants
- K182430Clearfil Majesty ICKuraray Noritake Dental, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943168 | Clearfil AP-X | Kuraray Company, Ltd. | 1994 | — |
| −1 | K012740 | Clearfil AP-X | Kuraray Medical, Inc. | 2001 | — |
| 0 (this device) | K061860 | Clearfil Majesty Esthetic | Kuraray Medical, Inc. | 2006 | — |
| +1 | K063595 | Clearfil Majesty Posterior | Kuraray America, Inc. | 2007 | — |
| +1 | K121583 | Clearfil Majesty Flow | Kuraray Noritake Dental, Inc. | 2012 | — |
| +2 | K071169 | Clearfil Majesty Posterior PLT | Kuraray Medical, Inc. | 2007 | — |
| +1 | K192178 | R&D Series Nova Compo N | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2019 | — |
| +2 | K182430 | Clearfil Majesty IC | Kuraray Noritake Dental, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K012740 | Clearfil AP-XSummary page 1…1676 Fax: (212)-867-3543 CLEARJ L MAJESTY Esthetic Tooth shude resin material (21 CFR section 872.3690. Product code: EBF) Restoralive composite resin 510(k) Mumber: K012740 Product (Code: EBF 21 CFR Hection: 872.3690 Applicant: KURARAY MEDICAL INC. 510(k) Mumber: K033267 Product Code: EBF 21 CF… | 2001 |
| * | K033267 | EpricordSummary page 1…. Product code: EBF) Restoralive composite resin 510(k) Mumber: K012740 Product (Code: EBF 21 CFR Hection: 872.3690 Applicant: KURARAY MEDICAL INC. 510(k) Mumber: K033267 Product Code: EBF 21 CFR 3ection: 872.3690 Applicant: KURARAY MEDICAL INC. 510(k) Mumber: K023814 Product Code: EBF 21 CFR… | 2003 |
| * | K023814 | Gradia DirectSummary page 1…Hection: 872.3690 Applicant: KURARAY MEDICAL INC. 510(k) Mumber: K033267 Product Code: EBF 21 CFR 3ection: 872.3690 Applicant: KURARAY MEDICAL INC. 510(k) Mumber: K023814 Product Code: EBF 21 CFR Section: 872.3690 Applicant: GC AMERICA, INC. 510(k) Mumber: K042819 Produc! Code: EBF 21 CFE Sect… | 2003 |
| * | K042819 | Tetric EvoceramSummary page 1…CFR 3ection: 872.3690 Applicant: KURARAY MEDICAL INC. 510(k) Mumber: K023814 Product Code: EBF 21 CFR Section: 872.3690 Applicant: GC AMERICA, INC. 510(k) Mumber: K042819 Produc! Code: EBF 21 CFE Section: 872.3690 Applicant: IVOCLAR VIVADENT, INC.… | 2004 |
What descends from it? (11)
See all 114 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 12 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K063595 (Kuraray America, Inc., 2007) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K012740.
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?
1) Direct restorations for anterior and posterior teeth (Class I - V cavities)
2) Direct veneers
3) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
4) Intraoral repairs of fractured crowns/bridges
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/K061860 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061860: Clearfil Majesty Esthetic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061860
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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