# K971733: 2 BOND 2

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Oct 2, 1997 after 146 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 2 bond 2 system is used for the seating of non-metal, laboratory fabricated restorations such as: Artglass, porcelain, ceramic and composite inlays, onlays, veneers, crowns, and bridges. 2 bond 2 is used for the seating of metal-supported, laboratory fabricated restorations such as: crowns, bridges, inlays/onlays Maryland bridges, brackets and splints.

Source page: https://510kreport.com/device/K971733
Methodology: https://510kreport.com/methodology