# K042614: S&C-Self Etch PR-Bond

- Pathway: 510(k) (Traditional)
- Applicant: S & C Polymer GmbH
- Decided: Nov 22, 2004 after 59 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- Jul 16, 2014 · Class II · Z-2128-2014: Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
- Jul 16, 2014 · Class II · Z-2129-2014: Septodont is recalling Self-Etch bond because the material was incorrectly packaged.

## Indications for use
S&C Self Etch Primebond is intended for bonding composites, compomers, and resin modified glass ionomer cements to enamel and dentin.

Source page: https://510kreport.com/device/K042614
Methodology: https://510kreport.com/methodology