# K160244: VARIOunite

- Pathway: 510(k) (Traditional)
- Applicant: Thommen Medical AG
- Decided: Jun 2, 2016 after 122 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: 12 generations back to K894595 (1990). 173 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121334: Varioeco, Thommen Medical AG (2012) Summary page 5.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 5.

## Most influential descendants
- K163634: External Hex Implants (2017), 13 descendants of its own
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K180465: Provata Implant System (2018), 2 descendants of its own
- K231967: ARi ExCon Implant System (2023), 1 descendant of its own

## Indications for use
VARIOflex Thommen Medical VARIOflex Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. VARIOtemp Thommen Medical VARIOtemp Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.

Source page: https://510kreport.com/device/K160244
Methodology: https://510kreport.com/methodology