510(k) · Cleared
ClearedTotal Etch Bonding Agent
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 Mar 20, 2007 as substantially equivalent to K003293 (Ivoclar North America, Inc., 2001) and 3 other predicates after a 125-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Mar 20, 2007
- Review
- 125 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K931812 (1993). 34 ancestors in all, the oldest K845033 (1985). No later device cites it as a predicate yet.
- Root · 7 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 6 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 5 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 4 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 3 generations backK982394 Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl. · 1998
- 2 generations backK023776 Xeno Iii Dental AdhesiveDentsply Intl. · 2003
- 1 generation backK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004
- This deviceK063444 Total Etch Bonding AgentDmg USA, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −6 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −5 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −4 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −3 | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive System | Dentsply Intl. | 1998 | — |
| −2 | K023776 | Xeno Iii Dental Adhesive | Dentsply Intl. | 2003 | — |
| −1 | K041960 | Composite/Compomer Repair Kit | Dmg USA, Inc. | 2004 | — |
| 0 (this device) | 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 |
| 1991 | 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 | 3 | 0 |
| 2002 | 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? (5)
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 |
|---|---|---|---|
| * | K003293 | Excite DSCSummary page 1…equivalent to several currently marketed dental restorative materials including the following: Total-Etch Dualbond: Excite DSC K003293 (Ivoclar North America Inc.) Optibond Solo Plus (Dual-cure) Unknown (Kerr Mfg. Co.) All Bond 2… | 2001 |
| * | K910628 | All Bond Liner-FSummary page 1…K003293 (Ivoclar North America Inc.) Optibond Solo Plus (Dual-cure) Unknown (Kerr Mfg. Co.) All Bond 2 K910628 (Bisco) Scotchbond MP Plus jK942493 (3M Espe) DMG USA, Inc.… | 1991 |
| * | K942493 | Scotchbond Multi-Purpose Plus Dental Adhesive SystemSummary page 1…ptibond Solo Plus (Dual-cure) Unknown (Kerr Mfg. Co.) All Bond 2 K910628 (Bisco) Scotchbond MP Plus jK942493 (3M Espe) DMG USA, Inc. March 1,2007 K063444/Am… | 1994 |
| * | K041960 | Composite/Compomer Repair KitSummary page 2…ch 1,2007 K063444/Amendment I Total Etch Bonding Agent Total-Etch Bond: Contax bonding agent contained in K041960 (DMG - USA) the DMG Composite / Compomer Repair Kit Safety and Performance: This submission contains safety and perfo… | 2004 |
| * | — | Optibond Solo Plus (Dual-cure) Named without a submission number |
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 14 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 34 ancestors has a recall.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
Total-Etch Dualbond is indicated for:
* Bonding resin-based materials (especially dual-cure composite / compomer materials) to tooth structure (dentin and enamel)
* Treatment of hypersensitive teeth
Total-Etch Bond is indicated for:
* Bonding resin-based materials (especially light-cure composite / compomer materials) to tooth structure (dentin and enamel)
* Treatment of hypersensitive teeth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063444: Total Etch Bonding Agent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063444
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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