# K953612: Imperva Fluorobond

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Oct 4, 1995 after 63 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K023842: Clearfil SE Bond Plus (2003), 3 descendants of its own
- K183391: Novidia Universal Bond (2019), 0 descendants of its own
- K122522: Dentoetch Quickbond Bond Activator (2013), 0 descendants of its own
- K070956: SEA2 Self Etch Adhesive (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K953612
Methodology: https://510kreport.com/methodology