# K051050: Sebond Pink Light 5G, Sebond Pink Dark 5G, Sebond Smart 5ML, Sebond Grip 3G, Models 644090, 644091, 640066, 644092

- Pathway: 510(k) (Traditional)
- Applicant: Schutz-Dental GmbH
- Decided: Jun 29, 2005 after 65 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
Sebond Pink Paste opaquer with integrated metal-resin bonding system, for framework retention (no additional bonder necessary) Sebond Smart, Odorless metal primer, universally suitable for all metals, guarantees a lasting bond. Sebond Grip Increases the bond (in combination with a metal primer, e. g. Sebond Smart) between metal and opaquer, for more safety and less spalling.

Source page: https://510kreport.com/device/K051050
Methodology: https://510kreport.com/methodology