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This document summarizes the premarket notification submission to the FDA for the Biodenta Dental Implant System, detailing its indications for use, device classification, and equivalence to predicate

How to fill out premarket notification 510k submission

How to fill out Premarket Notification / 510(k) Submission

1. Identify the device that you are submitting for 510(k) clearance.
2. Determine if your device is substantially equivalent to a legally marketed device.
3. Gather the necessary information regarding your device's design, materials, and intended use.
4. Compile performance testing data, including safety and effectiveness results.
5. Prepare the 510(k) submission covering all required sections such as labeling, clinical data, and manufacturing information.
6. Submit the 510(k) form and any supporting documentation through the FDA's Electronic Submission Gateway or by mail.
7. Pay the applicable fees for the submission, if required.
8. Monitor the status of your submission and respond to any requests for additional information from the FDA.

Who needs Premarket Notification / 510(k) Submission?

1. Manufacturers of medical devices that wish to market their product in the United States.
2. Companies introducing new medical devices that are similar to existing, approved devices.
3. Entities seeking to demonstrate that their device is safe and effective for its intended use to gain FDA clearance.

People Also Ask about

What is the FDA premarket approval number 510k?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

What is premarket approval in the FDA?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

What is the pre market notification process?

The premarket notification 510(k) process requires a medical device manufacturer to 'notify' FDA 90 days before they propose to begin marketing a new or certain modified device. This notification submission allows FDA to determine whether a device is substantially equivalent to one or more predicate devices.

What is the FDA 510k code?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What is a premarket submission number?

A premarket notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain U.S. marketing clearance.

What is the difference between 510k and premarket approval?

These two pathways determine the speed, complexity, and cost of your product's approval. While 510(k) clearance is used for most Class II devices with existing market equivalents, PMA (Premarket Approval) is required for high-risk or entirely novel Class III products.

What is the difference between premarket notification and 510k?

These two pathways determine the speed, complexity, and cost of your product's approval. While 510(k) clearance is used for most Class II devices with existing market equivalents, PMA (Premarket Approval) is required for high-risk or entirely novel Class III products.

When to submit a 510 K premarket notification?

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.” This significant effect could be positive or

For pdfFiller’s FAQs

What is Premarket Notification / 510(k) Submission?

Premarket Notification, or 510(k) Submission, is a regulatory pathway that manufacturers use to demonstrate that their new medical device is safe and effective by comparing it to a device that is already legally marketed in the U.S.

Who is required to file Premarket Notification / 510(k) Submission?

Manufacturers of medical devices that are classified as Class I and Class II are required to file a Premarket Notification / 510(k) Submission to the FDA before marketing their products.

How to fill out Premarket Notification / 510(k) Submission?

To fill out a Premarket Notification / 510(k) Submission, you must complete the FDA's 510(k) form, provide device descriptions, intended use, labeling, and compare it to a predicate device, along with any necessary safety and effectiveness data.

What is the purpose of Premarket Notification / 510(k) Submission?

The purpose of Premarket Notification / 510(k) Submission is to ensure that a new medical device is at least as safe and effective as an existing, legally marketed device before it can be sold to consumers.

What information must be reported on Premarket Notification / 510(k) Submission?

The information required includes the submitter's details, device classification, manufacturer's details, intended use, description of the device, labeling, and data demonstrating substantial equivalence to a predicate device.