510(k) · Cleared
ClearedClearfil Majesty Posterior
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray America, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Feb 9, 2007 as substantially equivalent to K061860 (Kuraray Medical, Inc., 2006) and 6 other predicates after a 67-day review. Its family tree reaches back 8 generations to 1993. 4 later devices descend from it.
- Decided
- Feb 9, 2007
- Review
- 67 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K931812 (1993). 52 ancestors in all, the oldest K833757 (1984). 4 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 backK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
- This deviceK063595 Clearfil Majesty PosteriorKuraray America, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK071169 Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK162967 nuance UNIVERSALDen-Mat Holdings, LLC · 2017
- Descendant · cites it directly · 0 of its ownK100328 Clearfil Majety PosteriorKuraray Medical, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK092281 Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007 · cites it directly1descendant
- K162967nuance UNIVERSALDen-Mat Holdings, LLC · 2017 · cites it directly0descendants
- K100328Clearfil Majety PosteriorKuraray Medical, Inc. · 2010 · cites it directly0descendants
- K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2009 · 2 generations on0descendants
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 | K042929 | Estenia C&B | Kuraray Medical Kurashiki Plant | 2004 | — |
| 0 (this device) | K063595 | Clearfil Majesty Posterior | Kuraray America, Inc. | 2007 | — |
| +1 | K071169 | Clearfil Majesty Posterior PLT | Kuraray Medical, Inc. | 2007 | — |
| +1 | K162967 | nuance UNIVERSAL | Den-Mat Holdings, LLC | 2017 | — |
| +1 | K100328 | Clearfil Majety Posterior | Kuraray Medical, Inc. | 2010 | — |
| +2 | K092281 | Clearfil Majesty Posterior PLT | Kuraray Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 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? (7)
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…mber: R001413) 3) Common name Restorative composite resin 3-3. Predicate device 1) CLEARFIL MAJESTY Esthetic 510,'k) Number: K061860 Classification: Tooth shade resin material… | 2006 |
| * | K012740 | Clearfil AP-XSummary page 1…,FRSection: 872.3690 Apjltlicant: KURARAY MEDICAL INC. 2) CLEARFIL AP-X 510ik) Number: K012740 C1,i.ssification: Tooth Shade Resin Material… | 2001 |
| * | K042929 | Estenia C&BSummary page 1…R Section: 872.3690 Applicant: KURARAY MEDICAL INC. 3) ESTENIA C&B 51i0(k) Number: K042929 C assification: Tooth shade resin material… | 2004 |
| * | K943170 | Clearfil Liner Bond 2Summary page 1…Section: 872.3690 Applicant: KURARAY MEDICAL INC. 4) CLEARFIL LINER BOND 2 5 10(k) Number: K943170 Classification: Resin tooth bonding agent… | 1994 |
| * | K993783 | Tetric FlowSummary page 1…Section: 872.3200 Applicant: KURARAY MEDICAL INC. 5) TETRIC FLOW 510(k) Number: K993783 11assification: Tooth shade resin material… | 1999 |
| * | K012442 | Modification to Clearfil SE BondSummary page 2…MEDICAL INC.] Section 3: 510(k) Summary 6) CLEARFIL SE BOND 510(k) Number: K012442 Classification: Resin tooth bonding agent… | 2001 |
| * | K012704 | Clearfil ST OpaquerSummary page 2…Section: 872.3200 Applic;ont: KURARAYMEDICALINC. 7) CLEARFILSTOPAQUER 510(k) Number: K012704 Classifrication: Tooth shade resin material… | 2001 |
What descends from it? (4)
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 14 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 52 ancestors has a recall.
- Of its descendants, K071169 (Kuraray Medical, Inc., 2007) has gone furthest, with 1 descendant 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. 2007, 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 anterior and posterior teeth (Class I - V cavities)
2) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
3) Intraoral repairs of fractured crowns/bridges
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063595: Clearfil Majesty Posterior.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063595
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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