# K111984: Spi Vario Angled Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Thommen Medical AG
- Decided: Nov 10, 2011 after 121 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: 3 generations back to K901927 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031747: Spi Dental Implant Abutments, Thommen Medical AG (2003) Summary page 2.
- K072856: Spi Variomulti Abutment, Thommen Medical AG (2008) Summary page 2.
- K090153: Spi Variomulti Angled Abutment, Thommen Medical AG (2009) Summary page 2.

## Indications for use
Thommen SPI® VARIO Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide Support for crowns or bridges.

Source page: https://510kreport.com/device/K111984
Methodology: https://510kreport.com/methodology