510(k) · Cleared
ClearedADH19
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Deutschland GmbH · KLE Agent, Tooth Bonding, Resin
Cleared on Oct 31, 2019 as substantially equivalent to K110302 (3M Espe AG, 2011) after a 9-day review. Its family tree reaches back 7 generations to 1990. 2 later devices descend from it.
- Decided
- Oct 31, 2019
- Review
- 9 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K900510 (1990). 36 ancestors in all, the oldest K833757 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 6 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 5 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 4 generations backK020256 Unicem3M Espe AG Dental Products · 2002
- 3 generations backK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- 2 generations backK071131 UNO3M Espe AG Dental Products · 2007
- 1 generation backK110302 Adhesive Exl-7593M Espe AG · 2011
- This deviceK192961 ADH193M Deutschland GmbH · 2019
- Descendant · cites it directly · 0 of its ownK260682 Bond-PR™ Universal AdhesivePremier Dental Products Company · 2026
- Descendant · cites it directly · 0 of its ownK222830 Rainbow 360Kerr Corporation · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −6 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −5 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −4 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| −3 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| −2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| −1 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| 0 (this device) | K192961 | ADH19 | 3M Deutschland GmbH | 2019 | — |
| +1 | K260682 | Bond-PR™ Universal Adhesive | Premier Dental Products Company | 2026 | — |
| +1 | K222830 | Rainbow 360 | Kerr Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K110302 | Adhesive Exl-759Summary page 4…CFR 872.3200, product code KLE) Device Class: .......................... Class II Predicate Devices .................... Scotchbond Universal (K110302) Description of Device ADH19 is a one-component dental adhesive that is based on the chemistry of Scotc… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 36 ancestors has a recall of any class.
- Of its descendants, K260682 (Premier Dental Products Company, 2026) has gone furthest, with 0 descendants of its own.
- 14 other devices also cite its predicate K110302.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Direct Indications: *Bonding for all methacrylate-based light-, dual-, and self-cure composite or compomer filling materials *Root surface desensitization *Bonding of methacrylate-based fissure sealants *Protective varnish for glass ionomer fillings *Repair of composite and compomer fillings *Sealing of cavities prior to placement of amalgam restorations Indirect Indications: *Cementation of indirect restorations in combination with Suglue 3 and other…
Read the full statement (116 words)
Direct Indications:
*Bonding for all methacrylate-based light-, dual-, and self-cure composite or compomer filling materials
*Root surface desensitization
*Bonding of methacrylate-based fissure sealants
*Protective varnish for glass ionomer fillings
*Repair of composite and compomer fillings
*Sealing of cavities prior to placement of amalgam restorations
Indirect Indications:
*Cementation of indirect restorations in combination with Suglue 3 and other resin cements (follow applicable Instructions for Use)
*Bonding for all methacrylate-based light-, self-, and dual-cure core build-up materials and cements
*Cementation of veneers when combined with RelyX Veneer Cement
*Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
*Sealing of cavities and preparation of tooth stumps prior to temporary cementation of indirect restorations
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192961: ADH19.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192961
Report an extraction error
Are you the manufacturer?
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