510(k) · Cleared
ClearedComposite/Compomer Repair Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmg USA, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Aug 30, 2004 as substantially equivalent to K002086 (Dmg USA, Inc., 2000) and 9 other predicates after a 40-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Aug 30, 2004
- Review
- 40 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 6 generations to K931812 (1993). 31 ancestors in all, the oldest K845033 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 5 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 4 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 3 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 2 generations backK982394 Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl. · 1998
- 1 generation backK023776 Xeno Iii Dental AdhesiveDentsply Intl. · 2003
- This deviceK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK063444 Total Etch Bonding AgentDmg USA, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K063444Total Etch Bonding AgentDmg USA, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −5 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −4 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −3 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −2 | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive System | Dentsply Intl. | 1998 | — |
| −1 | K023776 | Xeno Iii Dental Adhesive | Dentsply Intl. | 2003 | — |
| 0 (this device) | K041960 | Composite/Compomer Repair Kit | Dmg USA, Inc. | 2004 | — |
| +1 | K063444 | Total Etch Bonding Agent | Dmg USA, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
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
What was it cleared against? (10)
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 | Decided |
|---|---|---|---|
| * | K002086 | PrimaflowSummary page 1…dental restorative materials: Product Name 510(k) # Manufacturer PrimaFlow K002086 DMVG USA Zenith Flowable Composite K970683 Foremost Dental Mfg. Compo… | 2000 |
| * | K970683 | Zentih Flowable Composite (Multiple)Summary page 1…510(k) # Manufacturer PrimaFlow K002086 DMVG USA Zenith Flowable Composite K970683 Foremost Dental Mfg. Composite Repair K992879 DIVG-Hamburg C… | 1997 |
| * | K992879 | Ecusit Composite RepairSummary page 1…K002086 DMVG USA Zenith Flowable Composite K970683 Foremost Dental Mfg. Composite Repair K992879 DIVG-Hamburg Clearfill Repair K001914 Kuraray Co., Ltd. Perm… | 1999 |
| * | K001914 | Clearfil RepairSummary page 1…683 Foremost Dental Mfg. Composite Repair K992879 DIVG-Hamburg Clearfill Repair K001914 Kuraray Co., Ltd. PermaCem K012316 DMVG USA LuxaCore… | 2000 |
| * | K012316 | Permacem / Permacem DualSummary page 1…992879 DIVG-Hamburg Clearfill Repair K001914 Kuraray Co., Ltd. PermaCem K012316 DMVG USA LuxaCore/uxaCore Dual K012307 DMVG USA Solobond Plus… | 2001 |
| * | K012307 | Luxacore/Luxacore DualSummary page 1…K001914 Kuraray Co., Ltd. PermaCem K012316 DMVG USA LuxaCore/uxaCore Dual K012307 DMVG USA Solobond Plus K003153 Voco Tag Bong… | 2001 |
| * | K003153 | Solobond PlusSummary page 1…K012316 DMVG USA LuxaCore/uxaCore Dual K012307 DMVG USA Solobond Plus K003153 Voco Tag Bong IK845033 Foremost Dental Mfg. Xeno IIl… | 2000 |
| * | K845033 | Foremost Dentin AdhesiveSummary page 1…K012307 DMVG USA Solobond Plus K003153 Voco Tag Bong IK845033 Foremost Dental Mfg. Xeno IIl K<023776 Dentsply iBond… | 1985 |
| * | K023776 | Xeno Iii Dental AdhesiveSummary page 1…K003153 Voco Tag Bong IK845033 Foremost Dental Mfg. Xeno IIl K<023776 Dentsply iBond K<022612 Heraeus Kuizer Product Description/indicat… | 2003 |
| * | K022612 | Ibond Gluma InsideSummary page 1…45033 Foremost Dental Mfg. Xeno IIl K<023776 Dentsply iBond K<022612 Heraeus Kuizer Product Description/indications for Use: The Composite/Compomer Repair Kit consists of 4 materials: 1.A… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063444 | Total Etch Bonding Agent | 2007 | 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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 31 ancestors has a recall.
- Of its descendants, K063444 (Dmg USA, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 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?
The Composite/Compomer Repair Kit consists of 4 materials: 1. a general 6t h generation bonding agent for enamel and dentin, 2. a special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers, 3. a flowable compomer and 4. a flowable composite Bonding System (Contax) is indicated for • bonding chemically cured, light cured, or dual cured resin-based materials e. g. composite, compomer, ormocer materials to tooth…
Read the full statement (250 words)
The Composite/Compomer Repair Kit consists of 4 materials:
1. a general 6t h generation bonding agent for enamel and dentin,
2. a special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers,
3. a flowable compomer and
4. a flowable composite
Bonding System (Contax) is indicated for
• bonding chemically cured, light cured, or dual cured resin-based materials e. g. composite, compomer, ormocer materials to tooth structure (dentin and enamel)
• treatment of hypersensitive teeth
Composite Repair MMA-free is indicated
as a bonding agent for the intra- or extraoral repair of poor or damaged resin-based materials restorations
• as a bonding agent for composite-based posts
• for shade corrections of esthetically unsatisfying restorations
• for repair and completion of temporary crowns and bridges
• as a bonding agent on resin-based materials
PrimaFlow is indicated for
• minimally invasive restorations
• Class III and V restorations
• bases
• extended fissure sealing
• restorations of all classes of cavities in deciduous teeth
• as a temporary luting cement for e.g. veneers, and
• as a flowable compomer repair agent
Flowable Composite (LuxaFlow) is indicated as
• as an aesthetic anterior restoration
• a base restoration under posterior or anterior composites
• an add-on or repair material for provisional crowns & bridges
• for incorporation of most mechanically anchored attachment components into the acrylic base of an overdenture or partial denture.
• as a temporary luting cement for e.g. veneers, and
• as a flowable composite repair agent
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041960: Composite/Compomer Repair Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041960
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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