# K083876: Sfi-Bar System Complete 2-Implant and 4-Implant

- Pathway: 510(k) (Traditional)
- Applicant: Cendres & Metaux SA
- Decided: Feb 26, 2010 after 424 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
219 later devices descend from it; 6 cite it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K102382: Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss Implant (2010), 208 descendants of its own
- K111390: Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, Sfi-Bar (R) Implant Adapter Stra.. (2011), 201 descendants of its own
- K120414: Osseospeed Plus (2012), 196 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own

## Indications for use
The SF1-Bar is intended to be used with the SPI Element Platform 4.0 mm implant (K070007) to provide support for fixation of overdentures. The SF1 Bar consists of the following variants: SF1-Bar 2 Implant: Lower jaw: Connecting 2 or 2x2 implants in the intraforaminal region Upper jaw: Connecting 2x2 implants in the anterior/premolar region SF1-Bar 4 Implant: Lower jaw: Connecting 4 implants in the intraforaminal region Upper jaw: Connecting 4 implants in the anterior/premolar region

Source page: https://510kreport.com/device/K083876
Methodology: https://510kreport.com/methodology