# K191656: Zipbond

- Pathway: 510(k) (Traditional)
- Applicant: Sdi Limited
- Decided: Dec 2, 2019 after 164 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.
No later device cites it as a predicate yet.
0 of 37 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.

## Indications for use
Direct Applications: • Light cured composite restorations • Light cured compomers • Cavity sealing prior to placement of indirect restorations • Composite repair of porcelain and hybrid ceramic restorations • Sealing exposed root surfaces which are causing hypersensitivity • Core build ups using light cure/dual cure composites • Protective varnish for glass ionomer (GI) filling Indirect Applications: • Cementation indirect restorations

Source page: https://510kreport.com/device/K191656
Methodology: https://510kreport.com/methodology