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Nobel Biocare's SFB and CFB implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's SFB and CFB implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's SFB and CFB implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

The SFB and CFB - 5.0 Platform implants are similar to the predicate SFB and CFB implants. They differ only in platform diameter.

This document is a 510(k) summary for an endosseous dental implant. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a notification of intent to market and a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given input.

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Nobel Biocare's SFB and CFB implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's SFB and CFB implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's SFB and CFB implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Nobel Biocare TiUnite® Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The SFB and CFB implants are manufactured from commercially pure titanium. The implants utilize the TiUnite surface treatment and have the Groovy groove design feature.

Nobel Biocare SFB and CFB implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion where good initial stability can be obtained.

I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria. The document is a 510(k) summary for dental implants, which primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

The document describes:

• Device: SFB & CFB Implants
• Intended Use: Endosseous dental implants to support prosthetic devices.
• Predicate Devices: TiUnite Implants (K050705) and Groovy Implants (K050258).

There is no mention of:

• Specific acceptance criteria.
• Performance metrics (e.g., accuracy, sensitivity, specificity).
• Any study design (e.g., sample size, data provenance, ground truth establishment, expert adjudication).
• MRMC or standalone AI studies.

The letter from the FDA confirms that they have reviewed the 510(k) and found the device substantially equivalent to the predicate devices for its stated indications for use. This process relies on demonstrating similarity to already legally marketed devices, not necessarily on new performance studies against predefined acceptance criteria for the new device as would be the case for novel AI/ML devices or other complex technologies requiring extensive performance validation.

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