510(k) · Cleared

Cleared

Clearfil New Bond

K012734510(k) TraditionalCleared Sep 14, 200131-day reviewClass II21 CFR 872.3200

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

Kuraray Medical, Inc. · KLE Agent, Tooth Bonding, Resin

Cleared on Sep 14, 2001 as substantially equivalent to K943167 (Kuraray Company, Ltd., 1994) after a 31-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Sep 14, 2001
Review: 31 days
Class: Class II
Product code: KLE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K943167 (1994). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK943167 Clearfil New BondKuraray Company, Ltd. · 1994
This deviceK012734 Clearfil New BondKuraray Medical, Inc. · 2001
Descendant · cites it directly · 0 of its ownK131430 Clearfil DC Activator; Clearfil DC Activator TrialKuraray Noritake Dental, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all

K131430Clearfil DC Activator; Clearfil DC Activator TrialKuraray 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
−1	K943167	Clearfil New Bond	Kuraray Company, Ltd.	1994	—
0 (this device)	K012734	Clearfil New Bond	Kuraray Medical, Inc.	2001	—
+1	K131430	Clearfil DC Activator; Clearfil DC Activator Trial	Kuraray Noritake Dental, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K012734, 1994–2013Source: 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 KLE? 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 KLE device

#1 K262252 MPa Max adhesivescore 15.1 · 11 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? (1)

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
*	K943167	Clearfil New Bond Summary page 1 …ission is to alter the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. CLEARFIL NEW BOND by Kuraray Co., Ltd. (K943167) 4. Description for the premarket notification CLEARFIL NEW BOND is classified into Resin tooth bonding agent, CFR 21 Section 87…	Kuraray Company, Ltd.	1994	—

Also cleared against K943167: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K131430	Clearfil DC Activator; Clearfil DC Activator Trial	Kuraray Noritake Dental, Inc.	2013	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?

Its one ancestor has no recall.
Of its descendants, K131430 (Kuraray Noritake Dental, Inc., 2013) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K943167.

How does its category compare?

All KLE devices

KLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLE

3in 2025

2007high 14 (2007) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLE

149in 2025

2007high 195 (2020) · low 61 (2024)2026

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

Recalls per year · KLE

1in 2024

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KLE

3in 2025

2007high 260 (2014) · low 3 (2025)2025

MAUDE reports naming product code KLE, 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	14	71	2	18
2008	3	66	0	9
2009	7	79	1	11
2010	8	93	1	13
2011	10	100	0	69
2012	5	66	0	176
2013	11	115	0	248
2014	6	120	0	260
2015	10	118	0	100
2016	3	148	1	47
2017	4	171	1	42
2018	8	124	0	31
2019	6	143	0	20
2020	6	195	0	6
2021	4	163	0	6
2022	8	98	0	7
2023	6	75	0	7
2024	7	61	1	12
2025	3	149	0	3
2026	7	84	0	—

What is it indicated for?

CLEAFIL NEW BOND is indicated for the following applications:

1) A dentin and enamel bonding system for composite resin restoration

2) A dentin and enamel bonding system for amalgam restoration

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/K012734 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012734: Clearfil New Bond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012734

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026