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This document contains the 510(K) summary for the Swiss Plant Dental Implant System submitted by Implant Direct LLC, detailing the device's classification, description, intended use, and substantial

How to fill out swiss plant dental implant

How to fill out Swiss Plant Dental Implant System 510(K) Submission

1. Gather necessary documentation and information about the Swiss Plant Dental Implant System.
2. Prepare a comprehensive description of the device, including its intended use and design specifications.
3. Compile non-clinical and clinical data to demonstrate the safety and effectiveness of the implant system.
4. Include labeling and instructions for use that meet FDA requirements.
5. Develop a summary of substantial equivalence to demonstrate how your device compares to existing marketed devices.
6. Assemble the 510(k) submission package, ensuring all forms and documentation are complete.
7. Submit the 510(k) application to the FDA along with the required fee.
8. Respond to any FDA queries or requests for additional information during the review process.

Who needs Swiss Plant Dental Implant System 510(K) Submission?

1. Dental implant manufacturers seeking to market their Swiss Plant Dental Implant System in the United States.
2. Dental professionals looking to use the system in their practice and needing assurance of regulatory compliance.
3. Regulatory affairs specialists involved in the submission process for dental devices.

People Also Ask about

What does no one tell you about dental implants?

One of the less understood aspects of dental implants is the time required for full healing and integration with the jawbone. The process, known as osseointegration, can take several months as the titanium post fuses with the bone to create a stable foundation for the artificial tooth.

How do you get dental implants deemed medically necessary?

Often, an insurance company will ask a lot of questions in order to determine if dental implants meet their definition of a medical necessity. They may approve payment if a patient's tooth loss was the result of an accident, advanced gum disease, or other serious health problems, such as cancer or chronic GERD.

Are Swiss dental implants good?

Among them is the Swiss brand Straumann. The world's No. 1 manufacturer, Straumann, is the originator of many technologies and techniques in implantology. This implant brand, which our implantologists recommend and use, provides the best results.

Which type of dental implants has the highest success rate?

In general, titanium dental implants have shown the highest success rate. Because of this, most implants Aspen Dental teams place are made from titanium. It's important to note that the success of any dental implant also depends on individual factors such as oral health, bone quality and proper post-operative care.

What are the dental codes for implants?

Following are the CDT Codes for implants. D6010Surgical placement of implant body: endosteal implant D6012 Surgical placement of interim implant body for transitional prosthesis: endosteal implant D6013 Surgical placement of mini implant D6040 Surgical placement: eposteal implant D6050 Surgical placement: transosteal implant17 more rows • Jan 10, 2025

How long do Swiss implants last?

Ceramic implants are a lifelong solution with proper dental care and oral hygiene. On average, however, they last at least 15-20 years. We therefore recommend that you pay particular attention to oral hygiene.

Are Swiss dental implants good?

Among them is the Swiss brand Straumann. The world's No. 1 manufacturer, Straumann, is the originator of many technologies and techniques in implantology. This implant brand, which our implantologists recommend and use, provides the best results.

What is the success rate of Swiss implants?

Dental implants have a significantly high success rate, in the order of 98% lasting up to ten years. However, duration is subjective and depends on several factors, such as precision of the mechanical processing, bone features, oral hygiene and regular follow-up visits.

For pdfFiller’s FAQs

What is Swiss Plant Dental Implant System 510(K) Submission?

The Swiss Plant Dental Implant System 510(K) Submission is a premarket notification submitted to the FDA to demonstrate that a dental implant system is safe and effective for its intended use.

Who is required to file Swiss Plant Dental Implant System 510(K) Submission?

The manufacturer or importer of the Swiss Plant Dental Implant System is required to file the 510(K) Submission to obtain FDA clearance before marketing the product in the United States.

How to fill out Swiss Plant Dental Implant System 510(K) Submission?

To fill out the Swiss Plant Dental Implant System 510(K) Submission, the filer must provide detailed information about the device, including its design, materials, intended use, and comparison to a predicate device, along with any required testing data.

What is the purpose of Swiss Plant Dental Implant System 510(K) Submission?

The purpose of the Swiss Plant Dental Implant System 510(K) Submission is to establish that the new dental implant system is substantially equivalent to an already legally marketed device, thereby ensuring its safety and effectiveness for patients.

What information must be reported on Swiss Plant Dental Implant System 510(K) Submission?

The submission must report information such as device description, indications for use, labeling, technological characteristics, substantial equivalence comparisons, and any safety and efficacy data relevant to the dental implant system.