# K131526: Sfi-Bar

- Pathway: 510(k) (Traditional)
- Applicant: Cendres & Metaux SA
- Decided: Sep 23, 2013 after 118 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
Longest line of descent: 10 generations back to K960026 (1996). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083876: Sfi-Bar System Complete 2-Implant and 4-Implant, Cendres & Metaux SA (2010) Summary page 4.
- 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.., Cendres & Metaux SA (2011) Summary page 3.
- K071638: Biohorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc. (2007) Summary page 3.
- K042429: The Prodigy System Dental Implants, BioHorizons Implant Systems, Inc. (2004) Summary page 1.
- K073268: Biohorizons Internal Implant System, BioHorizons Implant Systems, Inc. (2008) Summary page 1.
- K053152: Biohorizons Single-Stage Implant, BioHorizons Implant Systems, Inc. (2005) Summary page 5.
- K073282: Biohorizons Single-Stage Implant System, BioHorizons Implant Systems, Inc. (2008) Summary page 1.

## Indications for use
The SFI-Bar® is intended to be used with the implant manufacturer's implant (Table 1) to provide support for fixation of overdentures. Only the implant systems listed in Table 1 may be used with SFI-Bar. The compatible implant systems are specified in Table 1 below.

Source page: https://510kreport.com/device/K131526
Methodology: https://510kreport.com/methodology