# K161774: i-Sil

- Pathway: 510(k) (Traditional)
- Applicant: Spident Co., Ltd.
- Decided: Sep 30, 2016 after 94 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: 5 generations back to K943574 (1994). 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)
- K152766: CharmFlex, Dentkist, Inc. (2016) Summary page 4.

## Indications for use
- Impression material in a dual phase impression technique - Precise duplication of models - Capturing multiple unit impressions

Source page: https://510kreport.com/device/K161774
Methodology: https://510kreport.com/methodology