510(k) Report

510(k) · Cleared

Cleared

Prelude

K040952510(k) TraditionalCleared Jun 29, 200478-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

Danville Materials, Inc. · KLE Agent, Tooth Bonding, Resin

Cleared on Jun 29, 2004 as substantially equivalent to K990498 (Sybron Dental Specialties, Inc., 1999) and 3 other predicates after a 78-day review. Its family tree reaches back 6 generations to 1993.

Decided
Jun 29, 2004
Review
78 days
Class
Class II
Product code
KLE
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K931812 (1993). 20 ancestors in all, the oldest K871636 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors1994: 5 other ancestors1993: 1 other ancestor1991: 1 other ancestor1987: 1 other ancestor1995: 1 other ancestorK931812 · New Dentine Adhesive · Dentsply Intl. · 1993K960823 · Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent · Dentsply Intl. · 1996K962348 · Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent · Dentsply Intl. · 1996K964525 · Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator · Dentsply Intl. · 1997K974486 · Clearfil Liner Bond 2V · Kuraray America, Inc. · 1998K990040 · Clearfil SE Bond · Kuraray Co. · 199919851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor5 generations back: 1 other ancestor K990040 · Clearfil SE Bond · Kuraray Co. · 1999K974486 · Clearfil Liner Bond 2V · Kuraray America, Inc. · 1998K964525 · Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator · Dentsply Intl. · 1997K962348 · Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent · Dentsply Intl. · 1996K960823 · Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent · Dentsply Intl. · 1996K931812 · New Dentine Adhesive · Dentsply Intl. · 1993−50
  1. Root · 6 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
  2. 5 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
  3. 4 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
  4. 3 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
  5. 2 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
  6. 1 generation backK990040 Clearfil SE BondKuraray Co. · 1999
  7. This deviceK040952 PreludeDanville Materials, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K931812New Dentine AdhesiveDentsply Intl.1993—
−5K960823Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl.1996—
−4K962348Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl.1996—
−3K964525Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl.1997—
−2K974486Clearfil Liner Bond 2VKuraray America, Inc.1998—
−1K990040Clearfil SE BondKuraray Co.1999—
0 (this device)K040952PreludeDanville Materials, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199110
199310
199450
199510
199820
199910
200110
200210
FIG. 1 — Lineage of K040952, 1993–2004Source: 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 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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K990498Optibond Solo Plus
Summary page 1
…edicate Device The device is substantially equivalent to other legally marketed devices in the United States including Optibond Solo Plus and Optibond Solo Plus 4 (K990498 & K014027), Clearfil SE (K990040) and Optibond Solo Plus Activator (K012082). Intended Use Prelude is a light cured adh…
Sybron Dental Specialties, Inc.1999—
*K014027Optibond Solo Plus 4
Summary page 1
…vice The device is substantially equivalent to other legally marketed devices in the United States including Optibond Solo Plus and Optibond Solo Plus 4 (K990498 & K014027), Clearfil SE (K990040) and Optibond Solo Plus Activator (K012082). Intended Use Prelude is a light cured adhesive desi…
Kerr Dental Materials Center20021
*K990040Clearfil SE Bond
Summary page 1
…s substantially equivalent to other legally marketed devices in the United States including Optibond Solo Plus and Optibond Solo Plus 4 (K990498 & K014027), Clearfil SE (K990040) and Optibond Solo Plus Activator (K012082). Intended Use Prelude is a light cured adhesive designed for direct restora…
Kuraray Co.1999—
*K012082Optibond Solo Plus Activator
Summary page 1
…marketed devices in the United States including Optibond Solo Plus and Optibond Solo Plus 4 (K990498 & K014027), Clearfil SE (K990040) and Optibond Solo Plus Activator (K012082). Intended Use Prelude is a light cured adhesive designed for direct restorations, i.e. composites and compomers to ena…
Sybron Dental Specialties, Inc.2001—

What descends from it?

No later submission names this one as a predicate yet.

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 11 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
  • 1 of the 20 ancestors has a recall of any class.

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?

Prelude is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges. When used with Prelude Activator, Prelude may also be used with self or dual cure materials.

Indications for use as stated in the FDA summary.

More from Danville Materials, Inc.

11 FDA decisions under this applicant name. See the company

  • K121880DMRC Nanoflow DMRC Nanocomposite Ebond Sure Etch Gel Sure Etch LiquidDanville Materials, Inc. · 2012
  • K111876Z Bond, Prelude OneDanville Materials, Inc. · 2011
  • K110642Siljetr SystemDanville Materials, Inc. · 2011
  • K102753Turbo Temp 3Danville Materials, Inc. · 2011
  • K092912Starfill 2B HV (High Viscosity) Rockcore, Model: 90838 and Starfill 2B LV (Low Viscosity), Model: 90150Danville Materials, 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/K040952 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040952: Prelude.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040952

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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