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The indications for use for the Nobel Perfect Implant System are the unmodified device, Replace Scalloped Margin Implant System. It is a system with a scalloped coronal implant designed for single stage or two stage surgical procedures. The Nobel Perfect Implant System is intended for use to restore chewing function in edentulous and/or partially edentulous patients.

The Nobel Perfect Implant System is a name change of the legally marketed device Replace Scalloped Margin Implant System. The Nobel Perfect Implant System utilizes the same components (i.e. implant, abutment, etc.) as the predicate device, Replace Scalloped Margin Implant System (K021584), yet contains three design modifications.

First, the screw-retained healing cap is now designed as a shorter, cover plug. The design modification was developed in order to attain a better seal and reduce the overall height of the implant by lowering its profile.

Second, a silicone o-ring has been added to the implant system. The o-ring is intended to be placed between the implant and the healing abutment in order to prevent fluids and tissue from seeping between the two parts during the healing process.

Third, changes in materials have been specified. The material used to manufacture the former screw-relained healing cap was acetal (Delrin). The cover plug and the o-ring will be made from a medical grade translucent silicone. The material used for the manufacture of the healing abutment has changed from acetal (Delrin) to polysulfone so that it may be radiation sterilized.

This device (K030257) is a dental implant system. The provided text indicates this is a "Special 510(k) Notification" for a name change and minor design modifications to a legally marketed predicate device (Replace Scalloped Margin Implant System, K021584).

A Special 510(k) pathway is used when a modification to a legally marketed device does not alter the device's fundamental scientific technology or its indications for use. For such submissions, the FDA typically relies on a comparison to the predicate device and does not require new clinical studies to demonstrate safety and effectiveness, as the modifications are deemed minor.

Therefore, the provided document does not describe a study that establishes acceptance criteria for new device performance, nor does it contain data from a study undertaken to prove those criteria are met for this specific device (Nobel Perfect Implant System).

Instead, the submission essentially states that because the Nobel Perfect Implant System is substantially equivalent to its predicate device (with only minor modifications that do not impact the fundamental performance or indications), it meets the same implicit acceptance criteria for safety and effectiveness as the predicate.

Here's why the requested information cannot be extracted from this document:

• No new performance data presented: Special 510(k)s focus on demonstrating that modifications do not negatively impact safety and effectiveness or change the intended use, rather than presenting new performance data against specific criteria.
• Reliance on predicate: The core of a Special 510(k) is the assertion that the modified device is as safe and effective as the predicate.

Given this, I cannot fill out the requested table or answer most of the specific questions as there is no new performance study data included in this 510(k) summary for the Nobel Perfect Implant System.

If this were a traditional Premarket Notification (510(k)) requiring new performance data, the information would typically be presented in sections like "Performance Data," "Bench Testing," "Biocompatibility," "Clinical Data," etc. Such sections are absent here because it is a Special 510(k).

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