# K123119: Ceraresin Bond

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Nov 28, 2012 after 56 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
CERAXESIN BOND is a light-curing bonding system for intracral and extracral repairs of dental ceramic and resin restorations or prostheses (facing crowns, veneers and implant superstructures) as well as artificial teeth (porcelain, hard resin and acrylic resin teeth) using direct/indirect composite. resin.

Source page: https://510kreport.com/device/K123119
Methodology: https://510kreport.com/methodology