# K252151: els unibond

- Pathway: 510(k) (Traditional)
- Applicant: Saremco Dental AG
- Decided: Dec 5, 2025 after 149 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: 8 generations back to K900510 (1990). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241445: K-Bond Universal, Spident Co., Ltd. (2024) Summary page 5.
- K110302: Adhesive Exl-759, 3M Espe AG (2011) Summary page 5.

## Indications for use
Direct restorations with light-curing composite-based materials. Indirect restorations: at the use of light-curing composite cements to fix inlays, onlays, crowns and bridges

Source page: https://510kreport.com/device/K252151
Methodology: https://510kreport.com/methodology