# K201684: A-Silicone for Bite Registration

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Huge Dental Material Corporation
- Decided: Sep 24, 2020 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: 1 generation back to K024034 (2002). 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)
- K024034: Occlufast Rock, Zhermack S.P.A. (2002) Summary page 4.

## Indications for use
A-Silicone for Bite Registration is indicated for making occlusal registrations.

Source page: https://510kreport.com/device/K201684
Methodology: https://510kreport.com/methodology