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Emulate Advanced

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072245

by Cavex Holland BV

Identifiers

510(k) Number
K072245 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)

Emulate Advanced is a dental impression material classified as a Class II medical device under FDA regulation 872.3660. It received traditional 510(k) clearance (K072245) on November 8, 2007, and was found substantially equivalent to a predicate device. The device is intended for use in dental applications as an impression material.

The device is manufactured by Cavex Holland BV and is supplied as a non-sterile, single-use or reusable material depending on clinical protocol. It is not MRI conditional or labeled for specific sterility; storage and handling should follow manufacturer instructions. No specific sizes or storage conditions are detailed in the provided data.

Frequently asked questions

What is Emulate Advanced used for?

Emulate Advanced is intended for use in dental applications as an impression material, as stated in its FDA 510(k) clearance documentation for Class II devices under regulation 872.3660.

Is Emulate Advanced sterile or non-sterile when supplied?

Emulate Advanced is supplied as a non-sterile material, and its sterility status depends on the clinical protocol followed by the user, as no specific sterility labeling is indicated in the device data.

Can Emulate Advanced be reused or is it single-use only?

Emulate Advanced may be used as either single-use or reusable depending on the clinical protocol, as the manufacturer does not restrict its use to a single application and leaves the determination to the clinician’s judgment and infection control practices.

What sizes or models of Emulate Advanced are available?

The provided device data does not specify any sizes, models, or reference numbers for Emulate Advanced beyond its name and manufacturer details, so no specific variants are documented in this record.

How should Emulate Advanced be stored?

Storage and handling of Emulate Advanced should follow the manufacturer’s instructions, as no specific storage conditions are detailed in the provided device data.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cavex Holland BV

Sources (1)

  • FDA 510(k) K072245 24 fields · synced Sep 23, 2026