# K043131: Torpicalgin

- Pathway: 510(k) (Traditional)
- Applicant: Zhermack S.P.A.
- Decided: Dec 15, 2004 after 33 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K143575: Accu-Dent XD Tray, Accu-Dent XD Syringe (2015), 0 descendants of its own

## Indications for use
Zhermack TROPICALGIN is a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.

Source page: https://510kreport.com/device/K043131
Methodology: https://510kreport.com/methodology