# K133071: Elastic Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Rizhao Huge Dental Industry Co., Ltd.
- Decided: May 28, 2014 after 240 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K241924: Elastic Impression Material (2024), 0 descendants of its own

## Indications for use
A Silicone DentisINy-Elnstie Impression Material, with the trade name of PERFIT. isan addition-cure vinyl polysiloxanec dental impression material that is used far all crown and bridge, edentulous. orthodontic and implant impression techniques.

Source page: https://510kreport.com/device/K133071
Methodology: https://510kreport.com/methodology