# K123278: Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self

- Pathway: 510(k) (Special)
- Applicant: Heraeus Kulzer, LLC
- Decided: Dec 7, 2012 after 46 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 K063062 (2006). 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)
- K063062: Hkbond 2006, Heraeus Kulzer, Inc. (2006) Summary page 1.

## Indications for use
M~ond Self Etch is an acetone/water-based formulation of light-activated methylacrylate resins. M~ond Self Etch is used for bonding of direct light-cured composite restorations (including Palyglaso and copomers), bonding of indirect restorations in combination with a light-curing luting cement; porcelain, Polyglas and composite restorations (inlays, onlays, veneers, crowns) and sealing hypersensitive areas of teeth.

Source page: https://510kreport.com/device/K123278
Methodology: https://510kreport.com/methodology