510(k) · Cleared

Cleared

Clearfil SA Cement

K081583510(k) TraditionalCleared Jul 28, 200853-day reviewClass II21 CFR 872.3275

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

Kuraray Medical, Inc. · EMA Cement, Dental

Cleared on Jul 28, 2008 as substantially equivalent to K032455 (Kuraray Medical, Inc., 2003) and 2 other predicates after a 53-day review. Its family tree reaches back 9 generations to 1993. 9 later devices descend from it.

Decided: Jul 28, 2008
Review: 53 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 3

Its longest line of descent runs back 9 generations to K931812 (1993). 24 ancestors in all, the oldest K871636 (1987). 9 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 9 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
5 generations between
3 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
2 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
1 generation backK062410 Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006
This deviceK081583 Clearfil SA CementKuraray Medical, Inc. · 2008
Descendant · cites it directly · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
Descendant · cites it directly · 5 of its ownK120379 Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia…Kuraray Medical, Inc. · 2012
Descendant · 2 generations on · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
Descendant · 3 generations on · 2 of its ownK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
Descendant · cites it directly · 1 of its ownK120378 Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia…Kuraray Medical, Inc. · 2012

Show all 9 generations

Root · 9 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
8 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
7 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
6 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
5 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
4 generations backK990040 Clearfil SE BondKuraray Co. · 1999
3 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
2 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
1 generation backK062410 Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006
This deviceK081583 Clearfil SA CementKuraray Medical, Inc. · 2008

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011high 3 (2015) · low 0 (2013)2026

Most influential descendants

Showing 5 of 9 · See all

K111982Clearfil DC Core PlusKuraray America, Inc. · 2011 · cites it directly6descendants
K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc. · 2012 · cites it directly5descendants
K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · 2 generations on4descendants
K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc. · 2015 · 3 generations on2descendants
K120378Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix…Kuraray Medical, Inc. · 2012 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K931812	New Dentine Adhesive	Dentsply Intl.	1993	—
−8	K960823	Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−7	K962348	Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−6	K964525	Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator	Dentsply Intl.	1997	—
−5	K974486	Clearfil Liner Bond 2V	Kuraray America, Inc.	1998	—
−4	K990040	Clearfil SE Bond	Kuraray Co.	1999	—
−3	K012442	Modification to Clearfil SE Bond	Kuraray Medical, Inc.	2001	—
−2	K032455	Panavia F 2.0	Kuraray Medical, Inc.	2003	—
−1	K062410	Clearfil Esthetic Cement & DC Bond	Kuraray Medical, Inc.	2006	—
0 (this device)	K081583	Clearfil SA Cement	Kuraray Medical, Inc.	2008	—
+1	K111982	Clearfil DC Core Plus	Kuraray America, Inc.	2011	—
+1	K120379	Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement…	Kuraray Medical, Inc.	2012	—
+2	K142625	PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value…	Kuraray Noritake Dental, Inc.	2015	—
+3	K150704	PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory…	Kuraray Noritake Dental, Inc.	2015	—
+1	K120378	Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement…	Kuraray Medical, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1991	1	0
1993	1	0
1994	5	0
1995	1	0
1998	2	0
2001	2	0
2004	2	0

Descendants by year cleared

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

FIG. 1 — Lineage of K081583, 1993–2021Source: 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 EMA? 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 EMA device

#1 K254109 G-Cem Universalscore 15.0 · 13 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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
*	K032455	Panavia F 2.0 Summary page 1 …Product code: EMA) 3) Common name Dental adhesive resin cement 3-3. Predicate device 1) PANAVIA F 2.0 510(k) Number: K03 2455 Product Code: EMA 21 CFR Section: 872.3275…	Kuraray Medical, Inc.	2003	—
*	K062410	Clearfil Esthetic Cement & DC Bond Summary page 1 …Applicant: KURARAY MEDICAL INC. 2) CLEARFIL ESTHETIC CEMENT & DC BOND 5 10(k) Number: K062410 Product Code: EMA 21 CFR Section: 872. 3275…	Kuraray Medical, Inc.	2006	—
*	K041474	Maxcem Summary page 1 …FR Section: 872. 3275 Applicant: KURARAY MEDICAL INC. 3) MAXCEM 510(k) Number: K04 1474 Product Code: EMA 21 CFR Section: 872. 3275…	Sybron Dental Specialties, Inc.	2004	—

Also cleared against K032455: 13 other devices →

What descends from it? (9)

3 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
K120379	Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…	Kuraray Medical, Inc.	2012	5
K120378	Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix…	Kuraray Medical, Inc.	2012	1

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 15 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
None of the 24 ancestors has a recall.
Of its descendants, K111982 (Kuraray America, Inc., 2011) has gone furthest, with 6 descendants of its own.
13 other devices also cite its predicate K032455.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · EMA

10in 2025

2007high 14 (2010) · low 2 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMA

106in 2025

2007high 245 (2022) · low 48 (2007)2026

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

Recalls per year · EMA

1in 2023

2007high 5 (2011) · low 0 (2007)2026

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

Adverse event reports per year · EMA

9in 2025

2007high 385 (2013) · low 3 (2022)2025

MAUDE reports naming product code EMA, 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	6	48	0	33
2008	13	71	2	50
2009	10	86	1	90
2010	14	86	1	106
2011	8	79	5	224
2012	10	128	0	249
2013	12	178	0	385
2014	4	174	0	207
2015	9	134	0	85
2016	10	182	0	16
2017	3	141	0	13
2018	3	237	0	4
2019	7	127	0	12
2020	8	164	0	5
2021	4	184	0	8
2022	7	245	0	3
2023	2	—	1	6
2024	3	59	0	5
2025	10	106	0	9
2026	7	150	0	—

What is it indicated for?

1) Cementation of crowns, bridges, inlays and onlays made of conventional porcelain, ceramic, hybrid ceramics, composite resin or metal

2) Cementation of metal cores, resin cores, metal posts or glass-fiber posts

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081583 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081583: Clearfil SA Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081583

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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