# K181604: Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite

- Pathway: 510(k) (Traditional)
- Applicant: Hrs Co., Ltd.
- Decided: Nov 28, 2018 after 162 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 K882690 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882690: Imprint Vinyl Polysiloxane Impression Material, 3M Company (1988) Summary page 4.
- K024034: Occlufast Rock, Zhermack S.P.A. (2002) Summary page 4.

## Indications for use
to obtain the structure of a patient’s teeth and gums

Source page: https://510kreport.com/device/K181604
Methodology: https://510kreport.com/methodology