# K031420: S & C -Bracket Adhesives

- Pathway: 510(k) (Traditional)
- Applicant: S & C Polymer GmbH
- Decided: Aug 20, 2003 after 107 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- 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. The FDA summary names its predicate without a number.
- (no number) Heliosit Orthodontic: named in the summary without a submission number
- (no number) Rely a Bond: named in the summary without a submission number

## Indications for use
Light cure bracket adhesive for the direct bonding of transparent glass ceramic brackets, plastic brackets and metal brackets. Dual cure bracket adhesive for the direct bonding of glass ceramic brackets, plastic brackets and metal brackets. One step bracket adhesive for the direct bonding of metal-, ceramic and plastic brackets.

Source page: https://510kreport.com/device/K031420
Methodology: https://510kreport.com/methodology