# K150933: iBond Universal & iBond Ceramic Primer

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, LLC, Mitsui Chemicals Group
- Decided: Jul 7, 2015 after 92 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
The iBond Universal System consists of iBond Universal bonding agent and iBond Universal Ceramic Primer. The iBond Universal indications are: Bonding of direct restoration for all cavity classes (Black) using light curing, dual curing or self-curing methacrylate based composites/compomers, Bonding of light curing dual curing or self-curing core build up materials, sealing of hypersensitive tooth areas, sealing of cavities prior to amalgam restorations, bonding of fissure sealants, sealing of cavities and core preparations prior to temporary cementation of indirect restorations(according to the immediate dentin sealing technique), cementation of indirect restorations with light curing dual-curing or self-curing adhesive resin cements, intraoral repair of composite and compomer restorations, porcelain fused to metal, all ceramic as well as metal restorations. The iBond Ceramic Primer indications are; surface conditioning of silicate/glass ceramic, specifically for the fixation of indirect restorations with luting composites, for intraoral repair of ceramic veneerings, as well as full ceramic restorations.

Source page: https://510kreport.com/device/K150933
Methodology: https://510kreport.com/methodology