# 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..

- Pathway: 510(k) (Special)
- Applicant: Cendres & Metaux SA
- Decided: Sep 12, 2011 after 117 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: 4 generations back to K894844 (1990). 7 ancestors in all.
201 later devices descend from it; 3 cite it directly.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073628: Synocta Abutments, Straumann USA (2008) Summary page 1.
- K083876: Sfi-Bar System Complete 2-Implant and 4-Implant, Cendres & Metaux SA (2010) Summary page 3.
- K102382: Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss Implant, Cendres & Metaux SA (2010) Summary page 1.

## Most influential descendants
- 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
- K150295: LOCATOR RTx (2015), 42 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own

## Indications for use
The SF1-Bar® is intended to be used with the implant manufacturer's implant (TABLE a) to provide support for fixation of overentures. Implant Company — Implant System — Implant Platform Diameter Institut Straumann — ITI Dental Implant System® — Standard 4.1 and 4.8 mm! / Standard. Plus 4.1 and 4.8 mm! / Tapered Effect 4.1 and 4.8 / Regular Neck (RN) 4.8 mm Thommen Medical — SPI® Element Platform — 4.0 mm Neoss — Neoss ProActive Implant — 3.5/4.0 /4.5 /5.0 /5.5 mm

Source page: https://510kreport.com/device/K111390
Methodology: https://510kreport.com/methodology