# K992001: Tray-Link

- Pathway: 510(k) (Traditional)
- Applicant: Silicon-Und Composite Spezialitaten GmbH
- Decided: Nov 2, 1999 after 140 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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 K984483 (1999). 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)
- K984483: A-Soft Reliner, S & C Polymer GmbH (1999) Summary page 1.

## Indications for use
Super adhesive system for adhering A-silicone and C-silicone impression materials on disposable plastic or light cured custom trays.

Source page: https://510kreport.com/device/K992001
Methodology: https://510kreport.com/methodology