# K171795: Thommen Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Thommen Medical AG
- Decided: Sep 29, 2017 after 105 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K960026 (1996). 280 ancestors in all.
No later device cites it as a predicate yet.
0 of 281 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093615: Spi Dental Implant, Element, Thommen Medical AG (2010) Summary page 4.
- K160244: VARIOunite, Thommen Medical AG (2016) Summary page 4.
- K102804: Spi Titanium Base for Cad/Cam, Thommen Medical AG (2011) Summary page 4.
- K151984: Thommen Milling Abutment for CAD/CAM, Thommen Medical AG (2016) Summary page 4.
- K121334: Varioeco, Thommen Medical AG (2012) Summary page 4.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 4.

## Indications for use
Implant: The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation and restoration in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and the central and lateral incisors of the lower jaw. VARIOunite PF 3.0: Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth). Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture. VARIOunite: Thommen Medical VARIOunite 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. Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

Source page: https://510kreport.com/device/K171795
Methodology: https://510kreport.com/methodology