# K071452: FL Bond II

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Jul 9, 2007 after 45 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
FL-BOND II is a dental bonding agent for composite resin to bond light-cured dental composite resin to tooth, metal, porcelain and resin for crown restorations. It consists of 3 materials, ETCHANT, PRIMER, and BONDING AGENT. Specific uses are as follows: 1. Filling restoration of tooth 2. Pretreatment of tooth, to which crown restoration is bonded using dental adhesive resin cement 3. Repair of crown restoration

Source page: https://510kreport.com/device/K071452
Methodology: https://510kreport.com/methodology