# K121334: Varioeco

- Pathway: 510(k) (Traditional)
- Applicant: Thommen Medical AG
- Decided: Aug 14, 2012 after 103 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: 9 generations back to K894595 (1990). 84 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071453: Spi Easy 4.0 Abutment, Thommen Medical AG (2007) Summary page 2.
- K031747: Spi Dental Implant Abutments, Thommen Medical AG (2003) Summary page 2.
- K103252: Camlog Vario SR Abutments, Altatec GmbH (2011) Summary page 2.

## Most influential descendants
- K160244: VARIOunite (2016), 15 descendants of its own
- 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

## Indications for use
Thommen VARIOeco dental implant 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/K121334
Methodology: https://510kreport.com/methodology