510(k) Report

510(k) · Cleared

Cleared

B1P Adhesive

K111431510(k) TraditionalCleared Aug 1, 201170-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

Pentron Clinical · KLE Agent, Tooth Bonding, Resin

Cleared on Aug 1, 2011 as substantially equivalent to K973388 (Jeneric/Pentron, Inc., 1997) and 2 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1997.

Decided
Aug 1, 2011
Review
70 days
Class
Class II
Product code
KLE
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K973388 (1997). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor1999: 1 other ancestorK973388 · Dentin Conditioning and Adhesive (Bond 1) · Jeneric/Pentron, Inc. · 1997 · recalled1995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors K973388 · Dentin Conditioning and Adhesive (Bond 1) · Jeneric/Pentron, Inc. · 1997 · recalled0
  1. Root · 1 generation backK973388 Dentin Conditioning and Adhesive (Bond 1)Jeneric/Pentron, Inc. · 1997 · Recalled
  2. This deviceK111431 B1P AdhesivePentron Clinical · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K973388Dentin Conditioning and Adhesive (Bond 1)Jeneric/Pentron, Inc.19972
0 (this device)K111431B1P AdhesivePentron Clinical2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200910
FIG. 1 — Lineage of K111431, 1997–2011Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K973388Dentin Conditioning and Adhesive (Bond 1)
Summary page 1
…nt, per 21 CFR § 872.3200 * Product Code: KE Devices for Which Substantial Equivalence is Claimed: *Pentron Clinical, Dentin Conditioning and Adhesive (Bond 1), K973388 *Kerr Corporation, Optibond Solo Plus 2, K(991808 *Heraeus Kulzer GmbH, lBond Total Etch, K(083652 Device Description:…
Jeneric/Pentron, Inc.19972
*K991808Optibond Solo Plus 2
Summary page 1
…s for Which Substantial Equivalence is Claimed: *Pentron Clinical, Dentin Conditioning and Adhesive (Bond 1), K973388 *Kerr Corporation, Optibond Solo Plus 2, K(991808 *Heraeus Kulzer GmbH, lBond Total Etch, K(083652 Device Description: SiP Adhesive is a fifth generation dental bonding agen…
Sybron Dental Specialties, Inc.19999
*K083652Ibond Total Etch
Summary page 1
…*Pentron Clinical, Dentin Conditioning and Adhesive (Bond 1), K973388 *Kerr Corporation, Optibond Solo Plus 2, K(991808 *Heraeus Kulzer GmbH, lBond Total Etch, K(083652 Device Description: SiP Adhesive is a fifth generation dental bonding agent that is intended to be used for direct composite bo…
Heraeus Kulzer,GmbH2009—

Also cleared against K973388: 3 other devices →

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?

  • 2 of the 3 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K973388.

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. 2011, 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?

SiP Adhesive is an adhesive designed to be used for all direct and indirect applications including, but not limited to, the following: Direct Applications * Direct bonding to dentin and/ or enamel * Bonding composite to composite, porcelain and/ or metal * Opaquing metal (used in conjunction with an opaque resin stain or cement) * Bonding with dual cure and self cure composite resins, such as cements and core build up materials * Amalgam sealing * Dentin…

Read the full statement (117 words)

SiP Adhesive is an adhesive designed to be used for all direct and indirect applications including, but not limited to, the following:

Direct Applications

* Direct bonding to dentin and/ or enamel

* Bonding composite to composite, porcelain and/ or metal

* Opaquing metal (used in conjunction with an opaque resin stain or cement)

* Bonding with dual cure and self cure composite resins, such as cements and core build up materials

* Amalgam sealing

* Dentin sealing

Indirect applications

* Indirect bonding of all composite, all ceramic, PFM and alloy crowns, bridges, inlays, onlays and veneers (used in conjunction with resin luting agents)

* Bonding of fiber and metal posts (in conjunction with resin luting agents)

Indications for use as stated in the FDA summary.

Also cleared against K973388

3 other devices cite the same predicate.

  • K013542Dentin Conditioning and Adhesive System (Bond-1)Jeneric/Pentron, Inc. · 2002
  • K994359Bond 1 C & BJeneric/Pentron, Inc. · 2000
  • K982692Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LCSterngold/Implamed · 1998

More from Pentron Clinical

4 FDA decisions under this applicant name. See the company

  • K130920Correct Plus 1Pentron Clinical · 2013
  • K120013Tempspan Clear MatrixPentron Clinical · 2012
  • K102703Build-IT Total CorePentron Clinical · 2011

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/K111431 · printed Nov 5, 2026

Cite this page

510(k) Report. “K111431: B1P Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111431

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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