510(k) · Cleared

Cleared

Clearfil Majesty Flow

K063593510(k) TraditionalCleared Feb 2, 200760-day reviewClass II21 CFR 872.3690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kuraray America, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Feb 2, 2007 as substantially equivalent to K993783 (Ivoclar North America, Inc., 1999) and 3 other predicates after a 60-day review. Its family tree reaches back 7 generations to 1993. 17 later devices descend from it.

Decided: Feb 2, 2007
Review: 60 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 4

Its longest line of descent runs back 7 generations to K931812 (1993). 21 ancestors in all, the oldest K871636 (1987). 17 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 7 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
6 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
5 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
4 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
3 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
2 generations backK990040 Clearfil SE BondKuraray Co. · 1999
1 generation backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
This deviceK063593 Clearfil Majesty FlowKuraray America, Inc. · 2007
Descendant · cites it directly · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
Descendant · cites it directly · 4 of its ownK111980 Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011
Descendant · cites it directly · 3 of its ownK121583 Clearfil Majesty FlowKuraray Noritake Dental, Inc. · 2012
Descendant · 3 generations on · 2 of its ownK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2011high 3 (2011) · low 0 (2014)2026

Most influential descendants

Showing 5 of 17 · See all

K111982Clearfil DC Core PlusKuraray America, Inc. · 2011 · cites it directly6descendants
K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · 2 generations on4descendants
K111980Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011 · cites it directly4descendants
K121583Clearfil Majesty FlowKuraray Noritake Dental, Inc. · 2012 · cites it directly3descendants
K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc. · 2015 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K931812	New Dentine Adhesive	Dentsply Intl.	1993	—
−6	K960823	Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−5	K962348	Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−4	K964525	Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator	Dentsply Intl.	1997	—
−3	K974486	Clearfil Liner Bond 2V	Kuraray America, Inc.	1998	—
−2	K990040	Clearfil SE Bond	Kuraray Co.	1999	—
−1	K012442	Modification to Clearfil SE Bond	Kuraray Medical, Inc.	2001	—
0 (this device)	K063593	Clearfil Majesty Flow	Kuraray America, Inc.	2007	—
+1	K111982	Clearfil DC Core Plus	Kuraray America, Inc.	2011	—
+2	K142625	PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value…	Kuraray Noritake Dental, Inc.	2015	—
+1	K111980	Clearfil Tri-S Bond Plus	Kuraray America, Inc.	2011	—
+1	K121583	Clearfil Majesty Flow	Kuraray Noritake Dental, Inc.	2012	—
+3	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
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	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	3	0
2012	1	0
2013	3	0
2015	3	0
2017	1	0
2019	3	0
2021	2	0
2023	1	0

FIG. 1 — Lineage of K063593, 1993–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K993783	Tetric Flow Summary page 1 …ve composite resin 4) Device listing number R001413 3-3. Predicate device 1) TETRIC FLOW 510(k) i" umber: K993783 Product Code: EBF (21 CFR Section: 872.3690)…	Ivoclar North America, Inc.	1999	—
*	K012740	Clearfil AP-X Summary page 1 …) Applicant: IVOCLAR NORTH AMERICA, INC. 2) CLEARFIL AP-X 510(k) Nlumber: K012740 Produci Code: EBF (21 CFR Section: 872.3690)…	Kuraray Medical, Inc.	2001	—
*	K033267	Epricord Summary page 1 …872.3690) Applic:nt: KURARAY MEDICAL INC. 3) EPRICORD 510(k) Number: K033267 Product Code: EBF (21 CFR Section: 872.3690)…	Kuraray Medical, Inc.	2003	—
*	K012442	Modification to Clearfil SE Bond Summary page 1 …872.3690) Applic',,t: KURARAY MEDICAL INC. 4) CLEARFIL SE BOND 510(k) Number: K012442 Product Code: KLE (21 CFR Section: 872.3200)…	Kuraray Medical, Inc.	2001	—

Also cleared against K993783: 6 other devices →

What descends from it? (17)

See all 17

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111982	Clearfil DC Core Plus	Kuraray America, Inc.	2011	6
K111980	Clearfil Tri-S Bond Plus	Kuraray America, Inc.	2011	4
K121583	Clearfil Majesty Flow	Kuraray Noritake Dental, Inc.	2012	3
K130371	Clearfil Majesty ES Flow	Kuraray Noritake Dental, Inc.	2013	0
K111975	Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory Pack	Kuraray Medical, Inc.	2011	0

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 4 companies; a new generation was cleared every 1.0 years on median.
None of the 21 ancestors has a recall.
Of its descendants, K111982 (Kuraray America, Inc., 2011) has gone furthest, with 6 descendants of its own.
6 other devices also cite its predicate K993783.

How does its category compare?

All EBF devices

EBF 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

2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007high 205 (2016) · low 43 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBF

1in 2020

2007high 42 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBF

1in 2025

2007high 246 (2013) · low 1 (2025)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?

CLEARFIL MAJESTY Flow is indicated for the following restorative applications:

- Direct restorations for anterior and posterior teeth (Class I - III, V cavities, cervical caries, root erosion)

- Cavity base / liner

- Intraoral repairs of fractured crowns / bridges / composite resin

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063593 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063593: Clearfil Majesty Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063593

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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