# K063718: SFB and CFB Implants - 5.0 Platform

- Pathway: 510(k) (Special)
- Applicant: Nobel Biocare AB
- Decided: Jan 5, 2007 after 22 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894595 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061003: SFB & CFB Implants, Nobel Biocare AB (2006) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K063718
Methodology: https://510kreport.com/methodology