510(k) Report

510(k) · Cleared

Cleared

Clearfil Tri-S Bond

K042913510(k) TraditionalCleared Nov 26, 200436-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 Nov 26, 2004 after a 36-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 26 later devices descend from it.

Decided
Nov 26, 2004
Review
36 days
Class
Class II
Product code
KLE
Recalls
None
Predicates
0

26 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2008: 3 descendants cleared2006: 2 descendants cleared2015: 3 descendants cleared2005: 1 descendant cleared2011: 3 descendants cleared2013: 3 descendants cleared2009: 2 descendants cleared2018: 3 descendants cleared2023: 1 descendant cleared2021: 2 descendants cleared2019: 2 descendants cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK042913 Clearfil Tri-S BondKuraray Medical, Inc. · 2004
  2. Descendant · cites it directly · 9 of its ownK061906 Clearfil Ceramic PrimerKuraray Medical, Inc. · 2006
  3. Descendant · cites it directly · 6 of its ownK062382 Clearfil DC BondKuraray Medical, Inc. · 2006
  4. Descendant · cites it directly · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
  5. Descendant · cites it directly · 4 of its ownK111980 Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011
  6. Descendant · 2 generations on · 3 of its ownK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22008: 32009: 22011: 32013: 32015: 32018: 32019: 22021: 22023: 12026: 1
2005high 3 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 26 · See all
  • K061906Clearfil Ceramic PrimerKuraray Medical, Inc. · 2006 · cites it directly9descendants
  • K062382Clearfil DC BondKuraray Medical, Inc. · 2006 · cites it directly6descendants
  • K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · cites it directly4descendants
  • K111980Clearfil Tri-S Bond PlusKuraray America, Inc. · 2011 · cites it directly4descendants
  • K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042913Clearfil Tri-S BondKuraray Medical, Inc.2004—
+1K061906Clearfil Ceramic PrimerKuraray Medical, Inc.2006—
+1K062382Clearfil DC BondKuraray Medical, Inc.2006—
+1K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value…Kuraray Noritake Dental, Inc.2015—
+1K111980Clearfil Tri-S Bond PlusKuraray America, Inc.2011—
+2K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200830
200920
201130
201330
201530
201830
201920
202120
202310
202610
FIG. 1 — Lineage of K042913, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K061906Clearfil Ceramic PrimerKuraray Medical, Inc.20069
K062382Clearfil DC BondKuraray Medical, Inc.20066
K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc.20154
K111980Clearfil Tri-S Bond PlusKuraray America, Inc.20114
K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc.20131
K110403Prolink Adhesives (Prolink, Prolink SE)Silmet, Ltd.20111
K080480Nanocomposite Restorative KitDmg USA, Inc.20081
K051796Clearfil Tri-S Bond Single DoseKuraray Medical Kurashiki Plant20051
K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc.20150
K111975Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKuraray Medical, Inc.20110

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?

  • Of its descendants, K061906 (Kuraray Medical, Inc., 2006) has gone furthest, with 9 descendants of its own.

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

2007: 142008: 32009: 72010: 82011: 102012: 52013: 112014: 62015: 102016: 32017: 42018: 82019: 62020: 62021: 42022: 82023: 62024: 72025: 32026 (partial year): 7
2007high 14 (2007) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLE

149in 2025

2007: 71 days median2008: 66 days median2009: 79 days median2010: 93 days median2011: 100 days median2012: 66 days median2013: 115 days median2014: 120 days median2015: 118 days median2016: 148 days median2017: 171 days median2018: 124 days median2019: 143 days median2020: 195 days median2021: 163 days median2022: 98 days median2023: 75 days median2024: 61 days median2025: 149 days median2026 (partial year): 84 days median
2007high 195 (2020) · low 61 (2024)2026

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

Recalls per year · KLE

1in 2024

2007: 22009: 12010: 12016: 12017: 12024: 1
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

2007: 182008: 92009: 112010: 132011: 692012: 1762013: 2482014: 2602015: 1002016: 472017: 422018: 312019: 202020: 62021: 62022: 72023: 72024: 122025: 3
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071471218
200836609
2009779111
2010893113
201110100069
20125660176
2013111150248
201461200260
2015101180100
20163148147
20174171142
20188124031
20196143020
2020619506
2021416306
202289807
202367507
2024761112
2025314903
20267840—

What is it indicated for?

CLEARFILTRI-S BOND is indicated for the following applications:

1)Direct restorations using light-cured composite resin

2)Cavity sealing as a pretreatment for indirect restorations

3)'Treatment of exposed root surfaces

4)lntraoral repairs of fractured crowns/bridges made of porcelain or composite resin

5)Surface treatment of prosthetic appliances made of porcelain or composite resin

6)Core build-ups using light- or dual- cured composite resin

Indications for use as stated in the FDA 510(k) statement.

More from Kuraray Medical, Inc.

42 FDA decisions under this applicant name. See the company

  • K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix (Universal (A2)…Kuraray Medical, Inc. · 2012
  • K120378Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix (Universal (A2)…Kuraray Medical, Inc. · 2012
  • K111975Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKuraray Medical, Inc. · 2011
  • K100328Clearfil Majety PosteriorKuraray Medical, Inc. · 2010
  • K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2009

Recent decisions in KLE

The KLE category page

  • K263680One Coat Bond; One Coat Bond SLDent4You AG · 2026
  • K262252MPa Max adhesiveDen-Mat Holdings, LLC · 2026
  • K260485Any-EtchMediclus Co., Ltd. · 2026
  • K260430Porcelain Etch GelBelport Company, Inc., Gingi-Pak · 2026
  • K252450Adhese 2Ivoclar Vivadent, Inc. · 2026

https://510kreport.com/device/K042913 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042913: Clearfil Tri-S Bond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042913

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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