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ACTA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K961735

by Satelec

Identifiers

510(k) Number
K961735 FDA 510(k)
FDA Product Code
EBZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6070 FDA 510(k)
Regulation Number
872.6070 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ACTA is a dental device classified as an Activator, Ultraviolet, For Polymerization. It is designed to facilitate polymerization processes in dental applications using ultraviolet technology.

The ACTA is manufactured by Satelec and is a Class II device with FDA 510K clearance (K961735). It is supplied in various models as indicated by the multiple registration numbers provided, though specific details regarding sterility, single-use or reusable status, MRI safety, and storage conditions are not specified in the provided data.

Frequently asked questions

What is the ACTA device used for in dental applications?

The ACTA is a dental device designed to facilitate polymerization processes using ultraviolet technology. It helps in the curing of dental materials that require UV light activation during various dental procedures.

Is the ACTA device single-use or reusable?

The provided data does not specify whether the ACTA device is single-use or reusable. For information regarding its intended use frequency, please consult the manufacturer's instructions or contact Satelec directly.

What are the regulatory approvals for the ACTA device?

The ACTA device has FDA 510K clearance (K961735) and is classified as a Class II device. It is manufactured by Satelec and is designed for dental applications, though specific details regarding sterility, MRI safety, and storage conditions are not provided in the data.

Are there different models of the ACTA device available?

Yes, the ACTA device is supplied in various models as indicated by the multiple registration numbers provided. However, the specific model differences and their corresponding features are not detailed in the provided information.

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
Satelec

Sources (1)

  • FDA 510(k) K961735 24 fields · synced Sep 23, 2026