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This document provides a summary of the 510(k) premarket notification for the PANAVIA SA CEMENT Handmix, a dental cement used for the cementation of various dental restorations, detailing its intended

How to fill out panavia sa cement handmix

How to fill out PANAVIA SA CEMENT Handmix 510(k) Summary

1. Begin with the product identification section, providing the name of the product: PANAVIA SA CEMENT Handmix.
2. Include the applicant's name and contact information.
3. Describe the intended use of the product clearly.
4. Provide a summary of the technological characteristics of the PANAVIA SA CEMENT Handmix.
5. Include a comparison with a predicate device, detailing similarities and differences.
6. Summarize the non-clinical performance testing conducted.
7. Outline the biocompatibility testing and results.
8. Detail the manufacturing process and quality control measures.
9. Include any additional data that supports the safety and efficacy of the product.
10. Finish with any regulatory history or additional information relevant to the 510(k) submission.

Who needs PANAVIA SA CEMENT Handmix 510(k) Summary?

1. Dental practitioners seeking to utilize PANAVIA SA CEMENT Handmix in their procedures.
2. Manufacturers and distributors of dental products who need to comply with regulatory standards.
3. Regulatory professionals involved in the approval process of dental materials.
4. Researchers studying dental adhesives and cements.

People Also Ask about

What is panavia cement used for?

The clinical indications for PANAVIA™ V5 include: cementation of crowns; bridges; inlays/onlays; veneers; adhesion bridges and splints, prosthetic restorations on implant abutment and frames; posts/cores; and amalgam bonding.

What is the strongest dental glue for bridges?

Zinc phosphate: Zinc phosphate has been in use for more than a century and is regarded as the gold standard for crown and bridge cement. It's also considered a final or permanent cement.

How do you use panavia universal cement?

4:42 6:07 Head light cure the margins of the post. Finally place the core buildup composite resin.MoreHead light cure the margins of the post. Finally place the core buildup composite resin.

What is Panavia used for?

The clinical indications for PANAVIA™ V5 include: cementation of crowns; bridges; inlays/onlays; veneers; adhesion bridges and splints, prosthetic restorations on implant abutment and frames; posts/cores; and amalgam bonding.

What can be cemented with panavia cement?

Due to its properties, PANAVIA™ SA Cement Universal is ideal for everyday procedures such as the permanent cementation of crowns and bridges made of zirconia, lithium disilicate, hybrid ceramic or even metal.

How long does it take for Panavia cement to set?

The final curing time is 5 minutes after placement of prosthetic restoration for self-curing. In the case of the cores and dental posts, seat the restoration in place for approximately 10 minutes and make sure the cement has been completely cured before preparing the abutment tooth.

For pdfFiller’s FAQs

What is PANAVIA SA CEMENT Handmix 510(k) Summary?

The PANAVIA SA CEMENT Handmix 510(k) Summary is a document submitted to the FDA that provides information about the safety and effectiveness of the PANAVIA SA CEMENT medical device, demonstrating that it is substantially equivalent to a legally marketed device.

Who is required to file PANAVIA SA CEMENT Handmix 510(k) Summary?

Manufacturers or sponsors of the PANAVIA SA CEMENT device who wish to market it in the U.S. are required to file the 510(k) Summary.

How to fill out PANAVIA SA CEMENT Handmix 510(k) Summary?

To fill out the PANAVIA SA CEMENT Handmix 510(k) Summary, the manufacturer must provide detailed information including device description, intended use, technological characteristics, performance data, and comparisons with predicate devices. Accurate documentation and adherence to FDA guidelines are essential.

What is the purpose of PANAVIA SA CEMENT Handmix 510(k) Summary?

The purpose of the PANAVIA SA CEMENT Handmix 510(k) Summary is to inform the FDA and the public about its safety and effectiveness in comparison to existing marketed devices, facilitating regulatory review and market access.

What information must be reported on PANAVIA SA CEMENT Handmix 510(k) Summary?

The information that must be reported includes the device name, intended use, description, summary of technological characteristics, data supporting safety and effectiveness, labeling, and any significant differences from predicate devices.