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This document is a 510(k) submission summary for the PaX-Uni3D, a dental radiographic imaging system, outlining safety and effectiveness information, device description, and regulatory compliance
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How to fill out 510k submission - pax-uni3d
How to fill out 510(k) Submission - PaX-Uni3D (PHT-7500)
01
Gather necessary documents including device description, indications for use, and proposed labeling.
02
Prepare a comprehensive summary of safety and effectiveness data.
03
Identify the applicable predicate device and provide its 510(k) number.
04
Complete the FDA Form 3514, providing detailed device information.
05
Compile performance testing results, including bench tests and clinical data if available.
06
Include any biocompatibility and sterilization data as applicable.
07
Create a detailed user manual and labeling for the device.
08
Submit the completed 510(k) submission electronically through the FDA's submission portal.
Who needs 510(k) Submission - PaX-Uni3D (PHT-7500)?
01
Manufacturers of the PaX-Uni3D (PHT-7500) dental imaging device.
02
Companies looking to market the device in the United States.
03
Entities seeking regulatory approval for a device that is similar to a legally marketed predicate device.
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People Also Ask about
What are class 1, class 2, and class 3 devices?
Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)
What are the different types of 510k submissions?
Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.
How long does a 510 K submission take?
The FDA maintains a database of premarket notification 510(k) submissions on its official website, enabling users to search for existing submissions using criteria such as the 510(k) number, applicant, device name or FDA product code.
What are the 4 types of FDA inspections?
The four different types of FDA inspections are pre-approval inspection, routine inspection, compliance follow-up inspection, and “for cause” inspection. Each is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different.
What are the three types of 510k?
Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.
What is the difference between abbreviated 510k and special 510k?
Special 510(k): Prove substantial equivalence to your own previously cleared device. Abbreviated 510(k): Prove substantial equivalence via compliance with FDA device-specific guidance documents, FDA special controls, or consensus device-specific standards.
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What is 510(k) Submission - PaX-Uni3D (PHT-7500)?
510(k) Submission for PaX-Uni3D (PHT-7500) is a premarket notification submitted to the FDA to demonstrate that the device is safe and effective for its intended use, and is substantially equivalent to a legally marketed device.
Who is required to file 510(k) Submission - PaX-Uni3D (PHT-7500)?
Manufacturers or importers of the PaX-Uni3D (PHT-7500) device who intend to market it in the United States must file a 510(k) submission.
How to fill out 510(k) Submission - PaX-Uni3D (PHT-7500)?
To fill out the 510(k) Submission for PaX-Uni3D (PHT-7500), one must complete the FDA's 510(k) application form, provide detailed descriptions of the device, its intended use, technological characteristics, performance data, labeling, and any comparisons to predicate devices.
What is the purpose of 510(k) Submission - PaX-Uni3D (PHT-7500)?
The purpose of the 510(k) Submission for PaX-Uni3D (PHT-7500) is to obtain FDA clearance to market the medical device, ensuring it is safe and effective for its intended use and is comparable to existing approved devices.
What information must be reported on 510(k) Submission - PaX-Uni3D (PHT-7500)?
The 510(k) Submission for PaX-Uni3D (PHT-7500) must report device identification, intended use, technological characteristics, summary of non-clinical and clinical testing, labeling, and any substantial equivalence arguments regarding predicate devices.
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