# K232978: DX. Bond V Dental Bonding Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Sino-Dentex Co., Ltd.
- Decided: Sep 22, 2023 after 1 day
- 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 K813180 (1982). 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)
- K813180: Scotchbond Dental Adhesive, 3M Company (1982) Summary page 7.

## Indications for use
Bonding for all Classes of direct composite restoration Bonding for indirect procedures involving metal, porcelain and composite

Source page: https://510kreport.com/device/K232978
Methodology: https://510kreport.com/methodology