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This document provides a summary of safety and effectiveness information for the 3M True Definition Scanner, an optical impression system used in dental practices.

How to fill out 3m true definition scanner

How to fill out 3M True Definition Scanner 510(k) Summary

1. Gather the necessary documentation that demonstrates the device's safety and effectiveness.
2. Complete the 510(k) submission form with the required information such as applicant name, device name, and device classification.
3. Provide a detailed description of the 3M True Definition Scanner, including its intended use and technological characteristics.
4. Include performance data and any relevant clinical studies that support the device's claims.
5. Clearly state the predicate devices to which the 3M True Definition Scanner is being compared.
6. Fill out the summary sections, ensuring that all required questions are answered accurately.
7. Review all sections for completeness and accuracy before final submission.
8. Submit the 510(k) summary electronically through the FDA's electronic submission system.

Who needs 3M True Definition Scanner 510(k) Summary?

1. Medical device manufacturers looking to market the 3M True Definition Scanner in the United States.
2. Regulatory professionals and quality assurance teams involved in device approval processes.
3. Healthcare providers interested in understanding the regulatory status of the 3M True Definition Scanner.

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What is 3M True Definition Scanner 510(k) Summary?

The 3M True Definition Scanner 510(k) Summary is a regulatory document submitted to the U.S. Food and Drug Administration (FDA) that provides information about the safety and effectiveness of the 3M True Definition Scanner. It includes details about the device's intended use, technology, and performance compared to predicate devices.

Who is required to file 3M True Definition Scanner 510(k) Summary?

Manufacturers or importers of the 3M True Definition Scanner seeking to market the device in the United States are required to file a 510(k) Summary with the FDA.

How to fill out 3M True Definition Scanner 510(k) Summary?

To fill out the 3M True Definition Scanner 510(k) Summary, manufacturers must provide detailed information about the device, including its description, intended use, technological characteristics, labeling, and data from performance testing. They must also identify predicate devices and demonstrate substantial equivalence.

What is the purpose of 3M True Definition Scanner 510(k) Summary?

The purpose of the 3M True Definition Scanner 510(k) Summary is to provide the FDA with sufficient information to assess the device's safety and effectiveness, ensuring that it is safe for use and substantially equivalent to existing marketed devices.

What information must be reported on 3M True Definition Scanner 510(k) Summary?

The information that must be reported includes device name and identification, intended use, description of the technology, comparisons to predicate devices, proposed labeling, and results of any testing conducted to support claims of safety and effectiveness.