510(k) · Cleared
ClearedAdhese 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Mar 5, 2026 as substantially equivalent to K210804 (Ivoclar Vivadent, AG, 2022) after a 213-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Mar 5, 2026
- Review
- 213 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K900510 (1990). 38 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 9 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 5 generations between
- 3 generations backK110302 Adhesive Exl-7593M Espe AG · 2011
- 2 generations backK133318 Adhese UniversalIvoclar Vivadent, AG · 2014
- 1 generation backK210804 Adhese Universal DC, Cention PrimerIvoclar Vivadent, AG · 2022
- This deviceK252450 Adhese 2Ivoclar Vivadent, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 8 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 7 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 6 generations backK020256 Unicem3M Espe AG Dental Products · 2002
- 5 generations backK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- 4 generations backK071131 UNO3M Espe AG Dental Products · 2007
- 3 generations backK110302 Adhesive Exl-7593M Espe AG · 2011
- 2 generations backK133318 Adhese UniversalIvoclar Vivadent, AG · 2014
- 1 generation backK210804 Adhese Universal DC, Cention PrimerIvoclar Vivadent, AG · 2022
- This deviceK252450 Adhese 2Ivoclar Vivadent, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −8 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −7 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −6 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| −5 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| −4 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| −3 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| −2 | K133318 | Adhese Universal | Ivoclar Vivadent, AG | 2014 | — |
| −1 | K210804 | Adhese Universal DC, Cention Primer | Ivoclar Vivadent, AG | 2022 | — |
| 0 (this device) | K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K210804 | Adhese Universal DC, Cention PrimerSummary page 5…sin (872.3200) (Classification Code KLE) Common Name: Resin tooth bonding agent Predicate Device: Adhese Universal DC (K210804) by Ivoclar Vivadent AG, Liechtenstein Device Description: Adhese® 2 is a dual-curing single-component dental adhesive for ena… | 2022 |
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 36 years and passes through 7 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 38 ancestors has a recall of any class.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
– Missing tooth structure – Defective restorations Areas of application: a. Pure self-curing of Adhese 2 only in combination with VivaPen DC cannulas and DC applicators – Adhesive cementation of indirect restorations and endodontic posts using Variolink® Esthetic DC in combination with all etching techniques. – Adhesive cementation of indirect restorations and endodontic posts using light- and dual-curing luting composites in combination with the etch &…
Read the full statement (200 words)
– Missing tooth structure
– Defective restorations
Areas of application:
a. Pure self-curing of Adhese 2 only in combination with VivaPen DC cannulas and DC applicators
– Adhesive cementation of indirect restorations and endodontic posts using Variolink® Esthetic DC in combination with all etching techniques.
– Adhesive cementation of indirect restorations and endodontic posts using light- and dual-curing luting composites in combination with the etch & rinse technique.
b. Light-curing of Adhese 2 at 500 to 1400 mW/cm2 (10 seconds) or at 1800 to 2200 mW/cm2 (5 seconds)
– Adhesive cementation of indirect restorations with light- and dual-curing luting composites
– Directly placed reconstructive build-ups and core build-ups made with light-, self- and dual-curing composites
– Directly placed light-curing composite and compomer restorations
– Repair of fractured composite and compomer restorations
– Desensitization of hypersensitive cervical areas
(Note: Provide additional cooling with an air syringe when applying the product.)
– Sealing of prepared tooth surfaces before temporary/permanent cementation of indirect restorations
c. Light-curing of Adhese 2 using Bluephase PowerCure in the 3sCure curing mode
– Only restorations in the posterior region of permanent dentition
(Class I and II, including the replacement of individual cusps) when light-cured from the occlusal aspect.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252450 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252450: Adhese 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252450
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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