# K252450: Adhese 2

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Mar 5, 2026 after 213 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K900510 (1990). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210804: Adhese Universal DC, Cention Primer, Ivoclar Vivadent, AG (2022) Summary page 5.

## Indications for use
– 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.

Source page: https://510kreport.com/device/K252450
Methodology: https://510kreport.com/methodology