# K192961: ADH19

- Pathway: 510(k) (Traditional)
- Applicant: 3M Deutschland GmbH
- Decided: Oct 31, 2019 after 9 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: 7 generations back to K900510 (1990). 36 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110302: Adhesive Exl-759, 3M Espe AG (2011) Summary page 4.

## Most influential descendants
- K260682: Bond-PR™ Universal Adhesive (2026), 0 descendants of its own
- K222830: Rainbow 360 (2023), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K192961
Methodology: https://510kreport.com/methodology