# K082157: Kettosil and Silginat

- Pathway: 510(k) (Traditional)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: Aug 6, 2008 after 6 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: 3 generations back to K812116 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070700: Freealgin, Zhermack S.P.A. (2007) Summary page 1.
- K974231: Position Penta, Position Penta Quick, Espe GmbH & Co. Kg. (1998) Summary page 1.
- K050604: Kerr VPS Impression Material, Sybron Dental Specialties, Inc. (2005) Summary page 1.

## Indications for use
Kettosil, Silginat and Silginat Strawberry are suitable for impressions in preparation of: • Preliminary impression • Anatomical models • Fabricating temporary crowns and bridges • Opposing dentition • Fabricating simple removable prosthetic restorations • Orthodontic work • Fabricating removable retainers and splints • Case study models • Producing models for the construction of trays for whitening solutions, bites and surgical guides.

Source page: https://510kreport.com/device/K082157
Methodology: https://510kreport.com/methodology