# K061003: SFB & CFB Implants

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jun 30, 2006 after 80 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: 6 generations back to K894595 (1990). 20 ancestors in all.
507 later devices descend from it; 7 cite it directly.
0 of 528 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050705: Tiunite Implants, Nobel Biocare AB (2005) Summary page 1.
- K050258: Groovy Implants, Nobel Biocare AB (2005) Summary page 1.

## Most influential descendants
- K071370: Nobelactive Internal Connection Implant (2007), 414 descendants of its own
- K062749: SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model 33701, CFB 15 Esthetic Abutment 2MM (2006), 327 descendants of its own
- K091756: Nobelprocera TI Abutment (2009), 278 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K101732: Astra Tech Implant System (2011), 214 descendants of its own

## 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/K061003
Methodology: https://510kreport.com/methodology