# K063062: Hkbond 2006

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Dec 1, 2006 after 57 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K123278: Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self (2012), 0 descendants of its own

## Indications for use
Bonding of direct composite restorations (including Polyglas® and Compomer) Bonding of indirect restoration in combination with a light-curing luting cement: Porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, crowns). Sealing hypersensitive areas of teeth.

Source page: https://510kreport.com/device/K063062
Methodology: https://510kreport.com/methodology