510(k) · Cleared
ClearedClearfil Majesty Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Noritake Dental, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Jul 25, 2012 as substantially equivalent to K061860 (Kuraray Medical, Inc., 2006) and 1 other predicate after a 56-day review. Its family tree reaches back 8 generations to 1993. 3 later devices descend from it.
- Decided
- Jul 25, 2012
- Review
- 56 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K931812 (1993). 25 ancestors in all, the oldest K871636 (1987). 3 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 7 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 6 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 5 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 4 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 3 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 2 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 1 generation backK063593 Clearfil Majesty FlowKuraray America, Inc. · 2007
- This deviceK121583 Clearfil Majesty FlowKuraray Noritake Dental, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK182430 Clearfil Majesty ICKuraray Noritake Dental, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK170873 Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi…Swissmeditec GmbH · 2017
- Descendant · cites it directly · 0 of its ownK130371 Clearfil Majesty ES FlowKuraray Noritake Dental, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See all- K182430Clearfil Majesty ICKuraray Noritake Dental, Inc. · 2019 · cites it directly0descendants
- K170873Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi…Swissmeditec GmbH · 2017 · cites it directly0descendants
- K130371Clearfil Majesty ES FlowKuraray Noritake Dental, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −7 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −6 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −5 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −4 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −3 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −2 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −1 | K063593 | Clearfil Majesty Flow | Kuraray America, Inc. | 2007 | — |
| 0 (this device) | K121583 | Clearfil Majesty Flow | Kuraray Noritake Dental, Inc. | 2012 | — |
| +1 | K182430 | Clearfil Majesty IC | Kuraray Noritake Dental, Inc. | 2019 | — |
| +1 | K170873 | Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque… | Swissmeditec GmbH | 2017 | — |
| +1 | K130371 | Clearfil Majesty ES Flow | Kuraray Noritake Dental, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K061860 | Clearfil Majesty EstheticSummary page 1…on name Dental light-cured restorative composite 3-3. Predicate device 1) CLEARFIL MAJESTY Esthetic 510(k) Number: K06 1860 Product Code: EBF 21 CFR Sec… | 2006 |
| * | K063593 | Clearfil Majesty FlowSummary page 1…Kuraray Noritake Dental Inc. 2) CLEARFIL MAJESTY Flow 510(k) Number: K063593 Product Code: EBF 21 CFR Sec… | 2007 |
What descends from it? (3)
3 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 19 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K182430 (Kuraray Noritake Dental, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K061860.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
1) Direct restorations for all cavity classes in anterior and posterior teeth
2) Direct veneers
3) Correction of tooth position and tooth shape (e.g. diastemna closure, dwarfed tooth, etc.)
4) Intraoral repairs of fractured restorations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121583: Clearfil Majesty Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121583
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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