# K962428: Ebs (Espe Bonding System)

- Pathway: 510(k) (Traditional)
- Applicant: Espe GmbH & Co. Kg.
- Decided: Sep 12, 1996 after 80 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: 1 generation back to K920424 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920424: Scotchbond Brand Multi-Purpose Adhesive System, 3M Company (1992) Summary page 1.

## Indications for use
The EBS® System is intended to bond composite materials to the tooth structure.

Source page: https://510kreport.com/device/K962428
Methodology: https://510kreport.com/methodology