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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.

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