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IL 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS PR 17 200 - accessdata fda

IL 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS PR 17 200 - accessdata fda 2025

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The document is a 510(k) summary for the Cyrtina System, a dental device intended for the fabrication of all-ceramic dental restorations such as crowns and bridges. It details the device's components, including the core material Cyrtina® BioZyram® and the overlay material Sakura® Interaction, both of which are designed for aesthetic dental applications. The summary includes information about predicate devices, intended use, technological characteristics, and FDA approval indicating that the Cyrtina System is substantially equivalent to existing legally marketed devices.

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What are the requirements for 510k clearance?

The FDA 510k submission requirements include extensive technical documentation such as proposed labeling, sterilization and shelf life data, biocompatibility research, animal, clinical and bench performance testing and other technical evidence needed to establish substantial equivalence and receive FDA 510k clearance.

What does FDA granted 510 K clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

How to view 510 k submissions?

Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.

What is FDA 510k approved?

The FDAs 510(k) submission process is, in a nutshell, a clearance process which every company wanting to bring a medium-risk medical device to the American market must pass through. Almost half of all medical devices used in the United States every day will have passed through the 510(k) route.

How long does FDA 510k clearance take?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

What is 510k summary of safety and effectiveness?

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) FDC Act).

How long does 501k clearance take?

The average length of time for clearance under the traditional 510(k) pathway is 177 days, or nearly six months. Just 19% of devices on the 510(k) pathway are cleared within three months. The average number of days it takes to clear a device via 510(k) varies ing to the device category.

IL 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS PR 17 200 - accessdata fda 2025

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