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EnvoyCem, Model 1640

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080032

by Envoy Medical Corporation

Identifiers

510(k) Number
K080032 FDA 510(k)
FDA Product Code
NEA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3275 FDA 510(k)
Regulation Number
872.3275 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

EnvoyCem is a glass ionomer cement used in dental applications. This device is designed for dental procedures and is classified as a Class II medical device.

The EnvoyCem, Model 1640 is supplied as a single-use device and is regulated under FDA 510(k) clearance K080032 with a product code of NEA. It is manufactured by Envoy Medical Corporation and is intended for dental use, with storage conditions not specified in the provided data.

Frequently asked questions

What is EnvoyCem Model 1640 used for?

EnvoyCem Model 1640 is a glass ionomer cement designed specifically for dental applications. It is intended for use in dental procedures where a cement material is required, though specific indications are not detailed in the provided information.

Is EnvoyCem Model 1640 a single-use device?

Yes, the EnvoyCem Model 1640 is supplied as a single-use device. This means it is designed for one patient procedure only and should not be reused or repackaged for subsequent use to ensure patient safety and device performance.

What is the regulatory status of EnvoyCem Model 1640?

EnvoyCem Model 1640 is regulated under FDA 510(k) clearance K080032 with a product code of NEA. It is classified as a Class II medical device and was determined to be substantially equivalent to predicate devices through the traditional clearance process.

What are the storage conditions for EnvoyCem Model 1640?

The storage conditions for EnvoyCem Model 1640 are not specified in the provided device data. For proper storage and handling, users should refer to the manufacturer's instructions or contact Envoy Medical Corporation directly for specific guidance.

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: Esteem® EnvoyCem® - BEUDAMED, Envoycem, Model 1640 510 (k) FDA Premarket Notification K080032 ENVOY ..., ENVOYCEM, MODEL 1640 (K080032) — FDA 510(k) | Innolitics, Envoycem, Model 1640 - Beudamed, AccessGUDID - DEVICE: EnvoyCem® (00812282020375)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Envoy Medical Corporation

Sources (1)

  • FDA 510(k) K080032 24 fields · synced Sep 24, 2026