# K182162: OptiBond eXTRa Universal

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Nov 7, 2018 after 89 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
Longest line of descent: 1 generation back to K101423 (2010). 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)
- K101423: Optibond XTR, Kerr Corporation (2010) Summary page 4.

## Indications for use
Direct Bonding 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 Bonding Applications Veneers. Self-cure, dual-cure, light-cure resin cements and core buildup materials. Porcelain, ceramic (including zirconia-based, lithium disilicate-based and alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges. Endodontic posts. Cavity sealing as a pretreatment for indirect restorations.

Source page: https://510kreport.com/device/K182162
Methodology: https://510kreport.com/methodology