510(k) Report

510(k) · Cleared

Cleared

CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack

K161042510(k) TraditionalCleared Oct 25, 2016195-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 Noritake Dental, Inc. · KLE Agent, Tooth Bonding, Resin

Cleared on Oct 25, 2016 after a 195-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Oct 25, 2016
Review
195 days
Class
Class II
Product code
KLE
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2023: 1 descendant cleared201620182020202220242026
  1. This deviceK161042 CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL…Kuraray Noritake Dental, Inc. · 2016
  2. Descendant · cites it directly · 0 of its ownK231039 CLEARFIL Universal Bond Quick 2Kuraray Noritake Dental, Inc. · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K231039CLEARFIL Universal Bond Quick 2Kuraray Noritake Dental, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond…Kuraray Noritake Dental, Inc.2016—
+1K231039CLEARFIL Universal Bond Quick 2Kuraray Noritake Dental, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K161042, 2016–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (1)

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

NumberDeviceApplicantDecidedDescendants
K231039CLEARFIL Universal Bond Quick 2Kuraray Noritake Dental, Inc.20230

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, K231039 (Kuraray Noritake Dental, Inc., 2023) has gone furthest, with 0 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. 2016, this device’s year, is highlighted.

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?

[1] Direct restorations using light-cured composite resin

[2] Cavity sealing as a pretreatment for indirect restorations

[3] Treatment of exposed root surfaces

[4] Treatment of hypersensitive teeth

[5] Intraoral repairs of fractured restorations

[6] Post cementation and core build-ups

[7] Cementation of indirect restorations

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

More from Kuraray Noritake Dental, Inc.

32 FDA decisions under this applicant name. See the company

  • K250673CERABIEN MiLaiKuraray Noritake Dental, Inc. · 2025
  • K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc. · 2024
  • K231039CLEARFIL Universal Bond Quick 2Kuraray Noritake Dental, Inc. · 2023
  • K220369Esthetic ColorantKuraray Noritake Dental, Inc. · 2022
  • K213147CERABIEN MiLaiKuraray Noritake Dental, Inc. · 2022

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/K161042 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161042: CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161042

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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