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TORPICALGIN

FDA 510(k)

Class II (US FDA 510(k))

510(k) K043131

by Zhermack S.P.A.

Identifiers

510(k) Number
K043131 FDA 510(k)
FDA Product Code
ELW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3660 FDA 510(k)
Regulation Number
872.3660 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

TORPICALGIN is a Class 2 Dental impression material. It is a device used in dental applications for taking impressions.

TORPICALGIN received FDA 510(k) clearance (K043131) through the Traditional pathway. It is manufactured by Zhermack S.P.A. and has product code ELW. The device is supplied as a dental impression material for use in clinical settings.

Frequently asked questions

What is TORPICALGIN used for?

TORPICALGIN is a dental impression material used in dental applications for taking impressions in clinical settings, as indicated in its device description and intended use.

How is TORPICALGIN supplied and is it sterile or single-use?

TORPICALGIN is supplied as a dental impression material for clinical use; however, the provided data does not specify whether it is sterile, single-use, or reusable, so no claim about sterility or reuse can be made from the given information.

What regulatory pathway was used for TORPICALGIN's clearance?

TORPICALGIN received FDA 510(k) clearance through the Traditional pathway, as stated in the device data under clearance_type and decision_description.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K043131 FDA 510 (k) - TORPICALGIN | Zhermack S.P.A., tropicalgin normal set - Dentsply Sirona

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zhermack S.P.A.

Sources (1)

  • FDA 510(k) K043131 24 fields · synced Sep 24, 2026