# K100347: Optibond SE

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Apr 30, 2010 after 77 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. The FDA summary names its predicate without a number.
- (no number) OptiBond All-In-One: named in the summary without a submission number

## Indications for use
OptiBond SE is a two-component self-etch universal adhesive system designed to be used for all direct and indirect applications including, but not limited to, the following: Direct Applications * Light-cured composite and compomer restorations * Composite/ceramic/metal repairs * Cavity sealing for amalgam restorations * Sealing of hypersensitive and/or exposed root surfaces * Core build-ups (self-cured, light-cured or dual-cured) Indirect applications * Veneers * Porcelain, composite, and metal-based (including zirconia-based and alumina-based) inlays, onlays, crowns, bridges * Endodontic posts * Cavity sealing as a pretreatment for indirect restorations

Source page: https://510kreport.com/device/K100347
Methodology: https://510kreport.com/methodology